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    About the author
    This webinar is all about Understanding the post-Brexit Medical Device regulations in UK and UKCA Certification requirements for manufacturers, join us for the webinar on May 25, 2022.
    Articles written by this author

    (Published: Thu, 06 May 2021 08:01:56 +0000)
    What is Structured Product Labeling SPL?, HL7, FDA, Regulatory submissions
    Structured Product Labeling (SPL) is a standard document approved and issued by Health Level Seven (HL7) to exchange information related to product and facility. It is used as a base for Regulatory guidance document in exchange for product labeling content. SPL ensures control over critical product
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:03:33 +0000)
    What is Biologics License Application?, BLA, Biologics, US FDA
    A Biologics License Application (BLA) is submitted to the Food and Drug Administration (FDA) to obtain permission for distribution of a biologic product across the states. It is regulated under 21 CFR 600-680. A BLA can be submitted by an applicant who is responsible for the safety and efficacy of t
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:05:49 +0000)
    Investigational Medical Product Dossier, IMPD Dossier, Europe
    The Investigational Medicinal Product Dossier (IMPD) is a document containing information about an investigational medicinal product (IMP) to be marketed in the EU. It includes various summaries of information related to the quality, manufacture and control of an IMP (including reference product and
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:07:13 +0000)
    What is Drug Master File? DMF Submissions, FDA, IND, NDA, ANDA
    A Drug Master File (DMF) is a type of submission made to the Food and Drug Administration (FDA) to provide important information related to facilities, processes or ingredients used for manufacturing, packaging or storing of any human drugs. Though it is not mandatory to file a DMF, the submission i
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:09:33 +0000)
    What is 505b1& 505b2? NDA, NCE, USFDA
    The 505(b)(1) is a USFDA (United States Food and Drug Administration) Regulatory pathway traditionally known as New Drug Application (NDA). The Regulatory pathway is used to obtain approval for new drugs with previously unapproved active ingredients. These type of submissions require extensive resea
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:10:40 +0000)
    What is 351 A and 351 K? BLA, FDA, biological products, PHS
    351(a) is the traditional pathway for approval of biologics and innovator biologics under the Public Health Service (PHS) act. Under section 351(a), the submitted application must contain all the information regarding the safety and effectiveness of a biological product. It is also known as a “sta
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:14:19 +0000)
    What is Pharmacovigilance System Master File? PSMF, MAH, Europe
    A Pharmacovigilance System Master File (PSMF) is a comprehensive document containing the detailed description of a Marketing Authorization Holders’ (MAH’s) pharmacovigilance (PV) system ensuring the safety of their products. An MAH, who holds market authorizations (MAs) for one or more medicinal
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:15:50 +0000)
    What is a gxp? GMP, GCP, GLP, FDA, Regulations, Guidelines
    GxP is a set of regulations and quality guidelines formulated to ensure the safety of life sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution. The GxP standards were established by the Food and Drug Administration
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:16:47 +0000)
    What is A Private Label, Private label distributors PLD
    When a product is manufactured by one company but sold and distributed under the brand name of another company, it is known as a private label product. Private labels are a response to the challenges faced by manufacturers such as lack of resources, monetary deficit or heavy workload. Alternatively,
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:18:28 +0000)
    What is Regulated Product Submission RPS?, HL7 Standard, FDA, PDUFA
    Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to help the processing and review of regulated product information. Initiated on June 22nd, 2005, RPS is created for the registration of pharmaceutical products for human use. The purpose of RPS is to meet the goals s
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:32:43 +0000)
    What is Periodic Safety Update Report PSUR?, EMA, Europe
    A Periodic Safety Update Report (PSUR) is a pharmacovigilance document which provides information related to the risk-benefit balance of a drug product post its authorization. The purpose of a PSUR is to give an overall analysis of the risk-benefits of the product, considering all the information (i
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:33:48 +0000)
    What is eCTD? electronic Common Technical Document, eCTD submissions
    eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health Authorities (HAs). It provides a harmonized solution to implement the Common Technical Document (CTD) electronically. An eCTD
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:34:54 +0000)
    What is Identification of Medicinal Products IDMP?, IDMP standards, medicinal products
    To harmonize specifications for identification and description of medicinal products internationally, a set of five EN/ISO international standards have been introduced. Identification of Medicinal Products (IDMP) provides base standards for identifying medicinal products uniquely to ensure smooth fu
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:36:01 +0000)
    What is new chemical entity NCE? Pharmaceuticals, USFDA
    A New Chemical Entity (NCE) is a drug that does not contain any active moiety that has been approved by the United States Food and Drug Administration (USFDA) with any other application. The manufacturers of an innovator drug generally develop a NCE during the early development stage of the product
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:37:01 +0000)
    What are Quasi Drugs? Beauty Products, South Korea, MFDS
    Quasi Drugs are one of the two primary categories of beauty products in South Korea. The other category of beauty products is cosmetics. There is a thin line between drugs and cosmetics, which can be considered as quasi-drugs. Since their benefits are not as suitable as drugs; South Korea’s health
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:38:10 +0000)
    What are purple and orange books? biological products, Generic Drugs, USFDA
    It is obvious that a bio-pharma product manufacturer would always first look for the existence of any similar product in the market. If it is to deal from the Regulatory perspective, the concern would be to chalk out their developmental/promotional strategies error-free. To enable all the generic dr
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:39:30 +0000)
    What Is A DUNS Number? Data Universal Numbering System DUNS, US FDA
    The Data Universal Numbering System, also known as DUNS number is a nine-digit unique identifier for businesses across the world. The DUNS number was created by Dun & Bradstreet (D&B), originally known as Mercantile Agency, in the year 1962 and is one of the oldest companies in the US. To obtain a D
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:50:54 +0000)
    What is PADER? Periodic Adverse Drug Experience Report, US FDA
    Periodic Adverse Drug Experience Report (PADER/PAER) is a part of post-cumulative safety reports which need to be submitted to the United States Food and Drug Administration (USFDA). The main purpose of a PADER is to update and evaluate a medicine’s global data and provide information about drug s
    Directory: Technology
    (Published: Thu, 06 May 2021 08:51:52 +0000)
    What is DHF? Design History File, medical device, USFDA
    Design History File (DHF) is a compilation of records that describes the design history of a finished device. The Design History File (DHF) was first mandated by the United States FDA in 1990 as part of the safe medical devices act; it contains all the product development documentation pertaining to
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:53:05 +0000)
    What is Product Information File PIF, CPSR, cosmetic products, Europe
    A Product Information File (PIF) is one of the most important legal requirements for placing a product in the market. Each cosmetic product is required to have a PIF of its own containing information about the product such as CPSR (Cosmetic Product Safety Report), product description, methods of man
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:54:42 +0000)
    What is Active Substance Master File, Certificate of Suitability, ASMF, EDMF, CEP
    An Active Substance Master File (ASMF), or formerly known as European Drug Master File (EDMF) procedure, is a set of documents that protects the valuable confidential intellectual property of the manufacturer. The purpose of an ASMF is to provide the Health Authorities (HAs) with complete informatio
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:55:38 +0000)
    what is individual case safety report?, ICSR, pharmacovigilance PV
    An Individual Case Study Report (ICSR) is a safety service document which includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product. It is an important facet of adverse event reporting which is a sour
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:58:45 +0000)
    What is SmPC? summary of product characteristics, Pharmaceutical, EMA
    SmPC or Summary of Product Characteristics is a legal document which is a part of the marketing authorization of every medicine. The document acts as a basis of information on the use of medicines for healthcare professionals. The information included in the SmPC is updated regularly as per the emer
    Directory: Advertising
    (Published: Fri, 21 May 2021 09:20:19 +0000)
    Introducing or importing Chemicals in Australia
    This article talks about the steps that must be followed by chemicals manufacturers to introduce/import their products in Australia to align with AICIS regulations.
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:11:59 +0000)
    What are purple and orange books? biological products, Generic Drugs, USFDA
    Purple book is a list of innovator biological products, including biosimilars and interchangeable biological products licensed by FDA under the PHS Act and the Orange book is a list of generic drugs approved by FDA
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:13:22 +0000)
    What is Corrective Action and Preventive Action, CAPA FDA
    Corrective Action Preventive Action (CAPA) is an approach used to investigate and resolve quality issues along with identifying their causes. It was introduced as a result of Food and Drug Administration’s (FDA) requirement under FDA 21 CFR 820.100. The CAPA mainly consists of two functions: Co
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:15:28 +0000)
    What is Post-Authorisation Safety Study, PASS, Imposed PASS, Voluntary PASS
    The post-authorization safety study (PASS) is a study conducted after a medicine has been authorized, to draw more information related to the safety of the medicine or to ensure the effectiveness of measures of risk management. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessmen
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:16:47 +0000)
    What is TPD? therapeutic product directorate, Health Canada
    The Therapeutic Product Directorate (TPD) is Canada’s federal authority responsible for regulations of prescription drugs for human use. In order to sell a prescription drug in Canada, scientific evidence for the product must be obtained from the directorate, as per the Food and Drug Regulations.
    Directory: Advertising
    (Published: Thu, 17 Jun 2021 13:43:09 +0000)
    What is office of generic drugs OGD? USFDA, generic drugs, CDER
    The Food and Drugs Administration’s Office of Generic Drugs (OGD) is a division under the Center for Drug Evaluation in Research (CDER) that focuses on the approval and facilitation of generic drugs. The purpose of the OGD is to ensure that the drug products distributed in the United States (US) a
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:45:56 +0000)
    What is Australian Public Assessment Report AusPAR? TGA, Australia
    The Australian Public Assessment Report (AusPAR) is an assessment report provided by the Therapeutic Goods Administration (TGA) to demonstrate the transparency of registration process of the prescription medicines. The purpose of the report is to provide information about the pre-registration proces
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:47:25 +0000)
    What is CE marking? Medical devices, Europe, CE certification, CE marking
    To sell a medical device in the European Union (EU), it is mandatory for manufacturers to obtain or apply for CE marking for the product. CE marking ensures that the medical device is compliant with the EU regulations and can be distributed in all the 32 European countries of the region. It is the r
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:48:44 +0000)
    Mexican Registration Holder, MRH, Medical devices licensing, COFEPRIS
    Mexico is possibly one of the most lucrative markets in Latin America, particularly for exporting medical devices. According to local legislation, any foreign manufacturer who wants to launch their products in Mexico should have a local office or must appoint a Mexican Registration Holder (MRH) for
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:50:25 +0000)
    eCOSMA Notification Process, Cosmetic Products Registration, SFDA
    Most of the cosmetic products in Saudi Arabia are imported, making it a lucrative market for the cosmetic industry. However, before a company can begin to market and sell their products in the Kingdom of Saudi Arabia, they must notify and register each product with the local health authority, Saudi
    Directory: Health
    (Published: Thu, 15 Jul 2021 11:09:10 +0000)
    EU CLP regulations on labeling and packaging requirements
    This article talks about the EU CLP regulations on labeling and packaging requirements for hazardous chemical substances/Mixtures.
    Directory: Health
    (Published: Thu, 15 Jul 2021 11:35:13 +0000)
    EU MDR Compliance & Key Requirements
    This article talks about the EU MDR Key Requirements for medical device manufacturers to be compliant.
    Directory: Health
    (Published: Wed, 21 Jul 2021 06:26:46 +0000)
    Food and Dietary Supplements Regulatory Pathways in Australia and New Zealand
    This article talks about the Food and Dietary Supplements Regulatory Pathways in Australia and New Zealand Markets.
    Directory: Health
    (Published: Wed, 21 Jul 2021 06:28:41 +0000)
    US EPA Regulations for registration of Disinfectants in USA
    This article talks about the US EPA regulations for disinfectant manufacturers to register their products in USA.
    Directory: Health
    (Published: Wed, 21 Jul 2021 06:48:36 +0000)
    Effective Regulatory Strategies for Medical Devices Registration Across the Globe
    This article talks about the effective regulatory strategies for Medical Devices registration across the globe.
    Directory: Health
    (Published: Fri, 06 Aug 2021 08:48:01 +0000)
    ISO 27001 Certification for Medical Devices Cybersecurity Compliance
    This article talks about the ISO 27001 Certification for Medical Devices to ensure Cybersecurity Compliance.
    Directory: Health
    (Published: Fri, 06 Aug 2021 08:49:32 +0000)
    GHS labeling requirements for Chemicals in the USA
    This article talks about the GHS new labeling requirements for Chemicals in the USAThis article talks about the GHS new labeling requirements for Chemicals in the USA
    Directory: Health
    (Published: Fri, 06 Aug 2021 08:51:05 +0000)
    5 Steps to Effectively Place Cosmetic Products on the EU Market
    This article talks about the 5 steps to effectively place cosmetic products on the European(EU) Market
    Directory: Health
    (Published: Fri, 06 Aug 2021 08:52:17 +0000)
    Swissmedic's New Medical Device Regulations
    This article talks about the Swissmedic’s new medical device regulations for manufacturers to successfully market their products in Switzerland.
    Directory: Health
    (Published: Fri, 06 Aug 2021 08:53:04 +0000)
    Medical devices QMS requirements for EU MDR and IVDR mandates
    This article talks about the EU MDR and IVDR QMS(Quality Management System) requirements for Medical device compliance.
    Directory: Health
    (Published: Fri, 06 Aug 2021 08:54:13 +0000)
    Key Aspects to Consider for Compliant 510k Submissions
    This article talks about the key aspects to consider for compliant FDA 510(k) Submissions. This article talks about the key aspects to consider for compliant FDA 510(k) Submissions.
    Directory: Health
    (Published: Fri, 06 Aug 2021 08:55:25 +0000)
    US FDAs Voluntary Cosmetic Registration Program VCRP and Prerequisites
    This article talks about the US FDA’s Voluntary Cosmetic Registration Program (VCRP) and its benefits & requirements for cosmetics manufacturers.
    Directory: Health
    (Published: Tue, 10 Aug 2021 05:21:04 +0000)
    EU MDRIVDR Impact on Australian Medical Device Approvals
    This article talks about EU MDR(European Medical device regulation)/EU IVDR (European Invitro Diagnostic regulations) imapct on Australian Medical Device Approvals.
    Directory: Health
    (Published: Wed, 11 Aug 2021 08:12:42 +0000)
    USFDA Clinical Outcome Assessments COA for medical devices
    This article talks about the USFDA’s Medical device Clinical Outcome Assessments (COA) that manufacturers may opt to include in the regulatory submissions for device approvals.
    Directory: Health
    (Published: Wed, 11 Aug 2021 08:13:26 +0000)
    Thai FDA New Medical device Regulations
    This article talks about the Thai FDA's new medical device regulations and transition timelines for successful market entry of products in Thailand.
    Directory: Health
    (Published: Fri, 27 Aug 2021 05:19:21 +0000)
    RAPEX - EU's Rapid Alert System to Identify Unsafe Consumer Products
    This article talks about the RAPEX (Rapid Exchange of Information System), a European Union’s rapid alert system to identify unsafe consumer products to ensure compliance.
    Directory: Health
    (Published: Wed, 08 Sep 2021 12:19:13 +0000)
    Importance of Color Pallet Conquests in Brand Building
    This article talks about the Importance of Color Pallet Conquests in brand building and establish brand identity in the minds of consumers.
    Directory: Health
    (Published: Wed, 08 Sep 2021 12:20:15 +0000)
    Thai FDA's New Medical Device Labeling Requirements
    This article talks about the Thailand TFDA’s new medical device labeling requirements which are effective from October 31, 2021 to ensure the safety of the end-users.
    Directory: Health
    (Published: Wed, 08 Sep 2021 12:24:20 +0000)
    Overview on Pharma Labeling Compliance Issues and HA Audit Findings
    This article talks about an Overview on Pharma Labeling Compliance Issues and HA Audit Findings. This article talks about an Overview on Pharma Labeling Compliance Issues and HA Audit Findings.
    Directory: Health
    (Published: Wed, 08 Sep 2021 12:27:32 +0000)
    Common Practices to Overcome Pharma Labeling Challenges
    This article talks about the common/best practices to overcome pharma labeling challenges. This article talks about the common/best practices to overcome pharma labeling challenges.
    Directory: Health
    (Published: Wed, 08 Sep 2021 12:28:53 +0000)
    Classification of Medical Devices and IVDs In Sri Lanka
    This article talks about the Classification of Medical Devices and In-Vitro diagnostics devices (IVDs) in Sri Lanka for compliant market entry.
    Directory: Health
    (Published: Wed, 08 Sep 2021 12:29:29 +0000)
    Post-Brexit Cosmetics Regulatory Changes in UK
    This article talks about the Post-Brexit Cosmetics Regulatory Changes for compliant market entry in UK
    Directory: Health
    (Published: Wed, 08 Sep 2021 12:31:10 +0000)
    Market Authorization of Medical Devices in Sri Lanka
    This article talks about the Market Authorization of medical devices in Sri Lanka. This article talks about the Market Authorization of medical devices in Sri Lanka.
    Directory: Health
    (Published: Wed, 08 Sep 2021 12:31:42 +0000)
    ANVISA Publishes Three 03 New Resolutions for Cosmetics
    This article talks about the Brazil’s ANVISA published Three (03) New Resolutions on August 11, 2021 for cosmetics, perfumes, and personal care products.
    Directory: Health
    (Published: Wed, 08 Sep 2021 12:32:21 +0000)
    ANATEL Certification Process for Wireless Medical Devices in Brazil
    This article talks about the Brazil’s ANATEL certification process of wireless medical devices/telecommunication products for ANVISA registration.
    Directory: Health
    (Published: Wed, 08 Sep 2021 12:32:57 +0000)
    An Exclusive Webinar on Indian Medical Device Regulatory Landscape - A Deep Dive
    webinar is all about Understanding the current Indian Medical Device Regulatory Landscape, join us for the webinar on September 22, 2021.
    Directory: Health
    (Published: Mon, 27 Sep 2021 10:28:28 +0000)
    Post-Brexit Medical Devices Regulatory Landscape in UK
    This article talks about the Post-Brexit medical device regulatory landscape in United Kingdom(UK). This article talks about the Post-Brexit medical device regulatory landscape in United Kingdom(UK).
    Directory: Health
    (Published: Mon, 27 Sep 2021 10:29:30 +0000)
    EU REACH Chemicals Registration Requirements
    This article talks about the EU REACH updated Chemicals registration requirements, which are effective from January 8, 2022.
    Directory: Health
    (Published: Mon, 27 Sep 2021 10:34:02 +0000)
    Overview on Borderline Products in the EU
    This article talks about an overview on Borderline products registration in the EU. This article talks about an overview on Borderline products registration in the EU.
    Directory: Health
    (Published: Mon, 27 Sep 2021 10:35:25 +0000)
    Key Considerations to Choose a Regulatory Submission Software
    This article talks about the Key Considerations to Choose a Regulatory Submission Software. This article talks about the Key Considerations to Choose a Regulatory Submission Software.
    Directory: Health
    (Published: Mon, 27 Sep 2021 10:36:19 +0000)
    Key factors to consider a right regulatory Labeling Software
    This article talks about the key factors to consider while choosing a right regulatory labeling software.
    Directory: Health
    (Published: Mon, 27 Sep 2021 10:37:30 +0000)
    NAFDAC Announces Sensitization Campaign in Nigeria
    This article talks about the NAFDAC announced commencement of a Sensitization Campaign in Nigeria. This article talks about the NAFDAC announced commencement of a Sensitization Campaign in Nigeria.
    Directory: Health
    (Published: Mon, 27 Sep 2021 10:38:38 +0000)
    MDCG's IVDR Implementation and Preparedness Plan
    This article talks about the MDCG's IVDR published joint implementation and preparedness plan for the In Vitro Diagnostics devices.
    Directory: Health
    (Published: Mon, 27 Sep 2021 10:58:41 +0000)
    Health Canadas Inspection Process for Licensed Medical Device Establishments
    This article talks about the Health Canada guidance on Inspection Process for Licensed Medical Device Establishments.
    Directory: Health
    (Published: Mon, 27 Sep 2021 10:59:45 +0000)
    Equivalent Review Pathway for Expedited Medical Device Registration in Mexico
    This article talks about the Equivalent review pathway for expedited medical device Registration in Mexico.
    Directory: Health
    (Published: Mon, 27 Sep 2021 11:01:12 +0000)
    Standard review pathway for medical device registration in Mexico
    This article talks about the Standard review pathway for medical device registration in Mexico. This article talks about the Standard review pathway for medical device registration in Mexico.
    Directory: Health
    (Published: Mon, 27 Sep 2021 11:02:07 +0000)
    Australia's TGA Updates on Regulation of Software as Medical Devices SaMDs
    This article talks about the Australia's TGA updates on Regulation of Software as Medical Devices (SaMDs).
    Directory: Health
    (Published: Mon, 27 Sep 2021 11:03:09 +0000)
    QMS Requirements for Medical Device Compliance in Mexico
    This article talks about the QMS Requirements for Medical Device Compliance in Mexico. This article talks about the QMS Requirements for Medical Device Compliance in Mexico.
    Directory: Health
    (Published: Mon, 27 Sep 2021 11:05:01 +0000)
    TGAs Black Triangle Scheme for Adverse Events in new prescribed medicines
    This article talks about the TGA’s Black Triangle Scheme for Adverse Events reporting in new prescribed medicines.
    Directory: Health
    (Published: Mon, 11 Oct 2021 07:40:17 +0000)
    Glimpse of Australia TGAs Overhaul for Medical Device Regulations
    This article talks about A Glimpse of Australia TGA’s Overhaul for Medical Device Regulations while entering Australian market. This article talks about A Glimpse of Australia TGA’s Overhaul for Medical Device Regulations while entering Australian market.
    Directory: Health
    (Published: Mon, 11 Oct 2021 07:40:55 +0000)
    PMS compliance requirements for Medical Devices in Thailand
    This article talks about the PMS (Post-Marketing Surveillance) compliance requirements for Medical Devices in Thailand. This article talks about the PMS (Post-Marketing Surveillance) compliance requirements for Medical Devices in Thailand.
    Directory: Health
    (Published: Mon, 11 Oct 2021 07:41:34 +0000)
    FSSAI Revises Nutraceuticals regulations 2021
    This article talks about the FSSAI revised Food Safety and Standards first amendment regulations 2021 for Nutraceuticals/food supplements manufacturers for smooth market entry of products.This article talks about the FSSAI revised Food Safety and Standards first amendment regulations 2021 for Nutrac
    Directory: Health
    (Published: Thu, 28 Oct 2021 11:10:32 +0000)
    DTAB advises New voluntary indication of VegNon-Veg Symbols on cosmetic products
    This article talks about the CDSCO's Drug Technical Advisory Board (DTAB) advises a new voluntary specification of Veg/Non-Veg symbols on Cosmetic Products in India.
    Directory: Health
    (Published: Wed, 08 Dec 2021 12:15:44 +0000)
    US FDA issued New Draft Guidance on Premarket Submissions of Device Software Functions
    This article talks about the US FDA issued new draft guidance on content of premarket submissions of device software functions
    Directory: Health
    (Published: Wed, 08 Dec 2021 12:17:54 +0000)
    An Overview on Regulation of Fragrances According to the US FDA
    This article talks about an overview on regulation of fragrances according to the US FDA. Medical Devices, SaMD, SiMD, US FDA, 21 CFR 820, SRS, Software Requirements Specification, SDS, software or System Design Specifications, Premarket Submissions, device software functions
    Directory: Advertising
    (Published: Tue, 21 Dec 2021 13:18:16 +0000)
    UK Implements Natashas Law for Prepacked Food Labels
    Any food product or ingredient, such as nuts, seafood, peanuts, gluten-containing cereal, latex, penicillin, etc., can pose allergies when ingested into a human body. According to research, generally, food allergies affect 2.5% of the general population. On October 1, 2021, the UK passed a new label
    Directory: Health
    (Published: Tue, 21 Dec 2021 13:20:34 +0000)
    TGA's New Milestones for the Registration of Prescription Drugs
    This article talks about the TGA’s New Milestones for the Registration of Prescription Drugs. Prescription Drugs, Regulatory Affairs, TGA Updates, Registration Process, TGA, Prescription Medicines
    Directory: Health
    (Published: Tue, 21 Dec 2021 13:23:53 +0000)
    Regulatory Standards for Medical Devices Cybersecurity
    This article talks about the Regulatory Standards for Cybersecurity of connected Medical Devices. Medical Devices, Connected Medical Devices, Software, Software as a Medical Device, Regulatory Standards, Cybersecurity
    Directory: Health
    (Published: Tue, 21 Dec 2021 13:24:27 +0000)
    Benefits of leveraging AIML for RIM digital transformation
    This article talks about the benefits of leveraging AI (Artificial Intelligence)/ML (Machine Learning) for RIM digital transformation to achieve regulatory goals.
    Directory: Health
    (Published: Tue, 21 Dec 2021 13:25:03 +0000)
    Deadline for Converting CAPs to UK Mas
    This article talks about the deadline for converting CAPs (Centrally Authorised Products) to UK MAs(Marketing Authorisations) before December 31, 2021.
    Directory: Health
    (Published: Tue, 21 Dec 2021 13:26:23 +0000)
    The Opportunity for Generic Companies and Value-Added Medicines in Africa
    This article talks about the opportunity for Generic companies and Value-Added Medicines in Africa. Market Access, Regulatory Affairs, Registration Strategy, Generic, Generic Companies, Value added medicines, African market
    Directory: Health
    (Published: Tue, 21 Dec 2021 13:27:24 +0000)
    List of Common Misconceptions about Meetings with the MHRA
    This article talks about the List of Common Misconceptions about Meetings with the MHRA. MHRA, Pharmaceuticals, Marketing Authorization, Regulatory Consulting, MA, Medicines and Healthcare products Regulatory Agency
    Directory: Health
    (Published: Tue, 21 Dec 2021 13:28:28 +0000)
    MHRA to update Regulations of Software and AI as a Medical Device
    This article talks about the UK’s MHRA to update Regulations of Software and AI(artificial intelligence) as a Medical Device. Medical Devices, SaMD, AiaMD, Software as a Medical device, Artificial Intelligence, MHRA, Medicines and Healthcare products Regulatory Agency, artificial intelligence
    Directory: Health
    (Published: Tue, 21 Dec 2021 13:29:24 +0000)
    FDA Essential Documents for Software as a Medical Device SaMD Pre-market Submissions
    This article talks about the FDA essential documents needed for Software as a Medical Device (SaMD) pre-market submissions to ensures patient safety and device efficiency.
    Directory: Health
    (Published: Tue, 21 Dec 2021 13:30:16 +0000)
    MHRA Extends the Free PPE Scheme till March 21, 2022
    This article talks about the UK’s MHRA extended free PPE Scheme till March 21, 2022 to control the rapid spread of COVID-19. This article talks about the UK’s MHRA extended free PPE Scheme till March 21, 2022 to control the rapid spread of COVID-19.
    Directory: Health
    (Published: Tue, 21 Dec 2021 13:31:18 +0000)
    USFDA Guidance on Electronic 510k Submission for Medical Devices
    This article talks about the USFDA issued guidance on Electronic 510(k) Submission for Medical Devices and benefits of the eSTAR. Medical Devices, 510(k) submissions, FDA, CDRH, eSTAR, Regulatory Affairs, US FDA, Electronic Submission
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:28:36 +0000)
    Reasons and Ramifications for Warning Letters 483s
    A warning letter is an official message/letter issued from a health authority to an organization that violates the set rules and regulations. When it relates to pharmaceutical companies, they need to follow several Good Manufacturing Practices (GMPs), GCPs, GDPs, etc., to avoid such warnings. There
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:30:11 +0000)
    EMAs Initiative for Regulatory Science Research Needs
    To note, there are many gaps in the Regulatory science that need to be addressed for the development and evaluation of medicine. Global Regulatory Agencies make strong efforts to close these gaps and enable access to innovative medicines that address the patient’s needs.
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:30:54 +0000)
    EC Plans to prevent Disruption of Medicines Supply Post-Brexit for Northern Ireland
    Based on the European Commission’s (EC) proposal on facilitating the movement of goods from Great Britain to Northern Ireland in October 2021, the Commission has now set up plans to maintain the medicines’ supply in specific markets post-Brexit.
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:31:32 +0000)
    FDAs Alternative Methods to Reduce Nitrosamine Impurity Levels in Drugs
    This article talks about the FDA’s alternative methods to reduce Nitrosamine Impurity levels in drug products.
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:32:27 +0000)
    Obligations of Economic Operators EOs under the Swissmedics MedDO
    There are various Economic Operators (EOs) who play a vital role in a device supply chain while delivering them to the point of use. Given the importance of each role, the Swiss Medical Device Ordinance (MedDO; SR 812.213) has set out the roles and responsibilities for each of these EOs. The three (
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:33:18 +0000)
    Comparative Analysis of TGAs 2018 and 2021 Advertising Codes
    To educate patients and Health Care Professionals (HCPs) and promote treatment options, the pharmaceutical industry like many other industries dedicates billions of dollars to advertise and promote prescription drugs. The legislative framework of advertising in Australia comes under Section 42BAA of
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:42:04 +0000)
    MHRAs Novel Approach for Enhanced Accessibility of Innovative Drugs in UK
    To enhance the accessibility of innovative medicines for patients in the UK post-Brexit, a new and accelerated approval pathway is known as the Innovative Licensing and Access Pathway (ILAP) was launched in January 2021. Its primary objective was to provide an integrated roadmap for all the stakehol
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:42:42 +0000)
    Health Canadas Preferred ANDS Gateway for Generic Drugs
    Canada ranks ninth in the world in value for generic drugs and has reached $5.8bn in sales as of today in 2022. To make effective, safe, and affordable drugs readily available to patients in the country, Health Canada – Canada’s Health Authority, is taking initiatives to improve the accessibilit
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:43:40 +0000)
    SPC Exception is a Boon for Generics and Biosimilars Manufacturers in the EU Market
    While innovators or branded drug products carry additional costs associated with the research and development of the product from the molecule identification stage to post-market authorization, generic drug products are relatively cost-effective. These therapies not only reduce the overall cost of t
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:44:15 +0000)
    ECs Electronic-IFU eIFU rules for medical devices
    Medical devices need an efficient, effective, and readily available user manual. Over time, paper Instructions for Use (IFU) have been the norm in the medical device industry. However, with the advent of electronic technologies, the paper IFU has been replaced by electronic IFU (eIFU).
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:46:31 +0000)
    Key Highlights from FSSAI Published Front Pack of Labelling FOPL Update
    FSSAI published a major update on the Front Pack of Labelling (FOPL) on 22nd February 2022 after a meeting with the stakeholders, to decide the remaining issues related to ‘Front of Pack Labelling’ under the Chairmanship of CEO, FSSAI. The FSSAI commenced the meeting with a presentation on the d
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:47:07 +0000)
    Regulation for Hair Colorants in the EU
    Hair colorants are classified as cosmetic products by the European Commission (EC) and are regulated under the regulation (EC) No: 1223/2009. Hair colorants contain a mixture of substances called hair dyes that are used to change the color of hair or to restore the original hair color.
    Directory: Health
    (Published: Thu, 03 Mar 2022 13:00:11 +0000)
    Pharmaceutical Labels and Errors to Avoid
    A pharmaceutical label is a monologue between the drug manufacturer and the patients. Miscommunication of any kind can affect the end-user. To protect the interest of the patient population, global Health Authorities (HAs) closely monitor pharmaceutical labels and indications of pre-approval. There
    Directory: Health
    (Published: Tue, 15 Mar 2022 13:48:24 +0000)
    DADI, An Upcoming Regulatory Business Transformation Project from the EMA
    This article talks about the EMA designed Digital Application Dataset Integration (DADI) project acts as replacement for the PDF-based electronic Application Form (eAF), which was incepted to support eCTD submissions. In addition to completing the requisite xEVMPD data submissions, life sciences or
    Directory: Health
    (Published: Mon, 04 Apr 2022 14:49:01 +0000)
    WHO Considerations for Regulating Cell and Gene Therapy Products CGTPs
    To promote global convergence among the Health Authorities and encourage the Member States to strengthen their Regulatory system on Cell and Gene Therapy products regulations, the WHO (World Health Organization) proposed a risk-based framework for regulating Cell and Gene Therapy Products (CGTPs). T
    Directory: Health
    (Published: Mon, 04 Apr 2022 14:49:40 +0000)
    EU Announces Clinical Trials Transformative Initiative
    Currently, the European clinical trials environment is quite challenging. The COVID-19 pandemic has shown a relative absence of EU impactful, multi-state trials. In addition, the disharmony of Regulatory requirements between the Member States has complicated the submission of multi-state trial appli
    Directory: Health
    (Published: Mon, 04 Apr 2022 14:50:17 +0000)
    USFDAs Emergency Use Authorizations
    Emergency Use Authorizations (EUAs) are significant in making life-saving medicinal products available to patients faster. They have been helpful in dealing with pandemics like COVID-19. An initiative of the United States Food and Drug Administration (USFDA) started in the year 2004, and the EUA cam
    Directory: Health
    (Published: Mon, 04 Apr 2022 14:50:56 +0000)
    US FDA Final Guidance on Population Pharmacokinetics
    After nearly two (02) decades of issuing the first draft guidance, the United States Food and Drug Administration (US FDA) finalized the guidance on population Pharmacokinetics (PK) in February 2022. The latest draft explains the application of population PK in drug development and recommendations o
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:10:28 +0000)
    Responsible Person RP, A Fundamental Requirement of the Cosmetic Industry
    To ensure that cosmetics align with the latest quality and safety standards, markets across the globe have stringent Regulatory requirements. In markets such as the European Union, the United Kingdom, Malaysia, India, Saudi Arabia, etc., appointing a Legal Representative/Responsible Person (RP)/ Loc
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:11:03 +0000)
    FDA published a series of updated guidance documents
    Recently, the FDA published three (03) guidance documents that focus on generic drug application submissions, labeling, and review. Among the three (03) guidance documents, two (02) are final drafts, and one (01) is a revised draft, which supports FDA’s Drug Competition Action Plan (DCAP) that was
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:11:36 +0000)
    Food Standards Australia New Zealand's FSANZ labeling standards for food products
    As you may know, every country has its own set of regulations when it comes to labeling food products. Food labeling is a legal requirement and provides a wide range of information to help consumers make informed food choices. It protects public health and safety by displaying ingredients, use-by da
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:12:10 +0000)
    EU Notified Bodies NBs Proposed Solutions for MDR & IVDR Implementation Challenges
    The European Notified Bodies (NBs) have published a new position paper to address the concerns of MDR/IVDR designated NBs. It will be effective from May 26, 2022 to May 26, 2024. The MDR/IVDR regulations aim to improve patient safety by strengthening the requirements for manufacturers and NBs.
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:13:06 +0000)
    EMRN Adopts a Common ePI Standard for Medicines in the EU
    The European Medicines Regulatory Network (EMRN) has adopted a common electronic Product Information (ePI) standard for human medicines. The common ePI standard was one of the major projects undertaken by the European Medicines Agency (EMA), the National Competent Authorities (NCA), and the European
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:13:56 +0000)
    An Overview on Therapeutic Products Regulation in New Zealand
    Medsafe, aka the New Zealand Medicines and Medical Devices Safety Authority, undertakes the regulation of therapeutic products in New Zealand. The Agency is a business unit of the Ministry of Health. It follows several legislations for regulating therapeutic products, the major ones being the Medici
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:14:32 +0000)
    Regulatory Overview on Sunscreens in Australia
    Sunscreen is an important component of an effective sun protection regime. They must be safe, effective, and of good quality. For this reason, the TGA regulates sunscreens as therapeutic goods in Australia under the Therapeutic Goods Act 1989. The Australian Regulatory Guidelines for Sunscreens (ARG
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:15:26 +0000)
    EMA Initiates DARWIN EU for RWE Integration in Medicines Assessment
    On February 09, 2022, the European Medicines Agency (EMA) commenced the establishment of a Coordination Centre for Data Analysis and Real-World Integration Network (DARWIN EU®). It is the first step towards integrating Real-World Evidence (RWE) into assessing medicines across the European Union (EU
    Directory: Health
    (Published: Wed, 20 Apr 2022 12:05:40 +0000)
    PAAB Complements the Standard Preclearance Pathway with Accelerated Review Options AROs
    This article talks about the PAAB (Pharmaceutical Advertising Advisory Board) Complement on the Standard Pre-clearance Pathway with Accelerated Review Options (AROs).
    Directory: Health
    (Published: Wed, 20 Apr 2022 12:06:11 +0000)
    HPRAs Perspective on multilingual labeling
    This article talks about the Health Products Regulatory Authority's (HPRA) Perspective on Multilingual Labeling.
    Directory: Health
    (Published: Wed, 20 Apr 2022 12:43:45 +0000)
    US FDA's cost-saving approach to the transition from CSV to CSA in 2022
    This article talks about the US FDA's cost-saving approach to the transition from Computer System Validation (CSV) to Computer Software Assurance (CSA) in 2022.
    Directory: Health
    (Published: Wed, 20 Apr 2022 12:44:47 +0000)
    FSSAIs New Labeling & Display Regulations for Pre-packed Foods
    This article talks about the FSSAI’s new labeling & display regulations for pre-packed foods.The Food Safety and Standards Authority of India (FSSAI) has divided the ‘Food Safety and Standards (Packaging and Labeling) Regulations, 2011’ into two (02) separate regulations: Food Safety and S
    Directory: Health
    (Published: Wed, 20 Apr 2022 12:45:17 +0000)
    Data-driven Regulatory Intelligence System for Life science Companies
    This article talks about the data-driven regulatory intelligence system for Life science companies to stay compliant with the new global Health Authority regulatory guidelines.
    Directory: Health
    (Published: Thu, 21 Apr 2022 06:20:51 +0000)
    Circular Economy: A New Era in the Polymer World
    This article talks about the European Commission’s strategy on recycling of plastic waste to achieve the Circular Economy.
    Directory: Advertising
    (Published: Fri, 06 May 2022 09:57:09 +0000)
    Regulatory Publishing & Submission with Automation
    This article talks about the transformation of regulatory publishing & submissions with automation to reduce the time and improve productivity.
    Directory: Health
    (Published: Fri, 06 May 2022 09:57:53 +0000)
    Health Canada Labeling standards for Cosmetic products in Canada
    This article talks about the Health Canada’s (HC) cosmetic labeling regulations and the importance of International Nomenclature of Cosmetic Ingredients (INCI) in Canada.
    Directory: Health
    (Published: Fri, 06 May 2022 09:58:49 +0000)
    Modernization of Food Regulations in Canada
    This article talks about the Modernization of Health Canada’s Food Regulations to ensure safety and smooth market entry of products in Canada.
    Directory: Health
    (Published: Thu, 12 May 2022 15:27:57 +0000)
    An Exclusive Webinar on Medical Devices in the UK & UKCA Certification Readiness
    Europe is the busiest region with evolving Regulatory landscape, as Brexit compliance, application of the EU MDR, transition to UKCA marking, and upcoming IVDR deadline take the front seat. All these dynamics have kept the Regulatory professionals on their toes. The UKCA mark came into effect on Jan
    Directory: Health

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