| (Published: Mon, 08 Aug 2022 15:29:47 +0000) |
| Labeling Requirements for California's Cleaning Products |
| Cleaning product labels are no different than labels for other consumer goods when disclosure of ingredients comes into play. Organizations should exercise safety practices that will protect the consumers and workers during consumption. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 08 Aug 2022 15:26:52 +0000) |
| Overview on Electronic Product Information ePI Labeling |
| In 1999, the European Medicines Assessment Agency (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) set out to design a new system to share product information electronically to support the submission of new products or variations post-approval. This was called |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 08 Aug 2022 15:26:10 +0000) |
| An Overview on Quality Review of Document QRD |
| This article talks about the overview on Quality Review of Document (QRD) of medicines in Europe
To market medicinal products in the European Union (EU) countries, pharmaceutical companies must prepare and translate documents like the Summary of Product Characteristics (SmPCs), Patient Information |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 04 Aug 2022 14:06:58 +0000) |
| South Koreaâs MFDS regulations on AI-based Medical Devices |
| The technological advancement is now an integral part of healthcare and Artificial Intelligence (AI) algorithms, along with other AI-powered applications supporting medical professionals in clinical settings. AI and Machine Learning (ML)-based Software as a Medical Device (SaMD) aid medical practiti |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 04 Aug 2022 14:06:05 +0000) |
| Role of Marketing Authorization Holder MAH for medical device registration in Japan |
| Globally, the Health Agencies require foreign medical devices and IVD manufacturers to appoint a local representative. In Japan, under the revised Pharmaceuticals and Medical Device (PMD) Act, the In-Country Caretaker (ICC) system was replaced with Marketing Authorization Holder (MAH) system. Under |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 25 Jul 2022 15:28:59 +0000) |
| Key requirements for Pharmaceutical Serialization |
| With serialization legislation introduced in two (02) major drug markets, namely, the USA and the EU, the pharma industry is being forced to take action on a large scale. On the other side, people are slowly realizing the benefits that serialization could bring in terms of patient safety and supply |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 25 Jul 2022 15:28:18 +0000) |
| Evolving with Pharmaceutical Serialisation, Tracking and Tracing |
| "In-depth analyses will highlight how pharmaceutical packaging, labeling, serialization, tracking, and traceability enhance consumer safety and transparency in the supply chain, as well as benefit pharmaceutical packaging that go beyond compliance with laws.
As the pharmaceutical industry continu |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 30 Jun 2022 07:15:08 +0000) |
| Regulatory Intelligence RI: The Focal Point of Your Business |
| This article talks about the importance of integrating Regulatory Intelligence (RI) Solutions with your Business to overcome the current challenges in the industry. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 30 Jun 2022 07:14:09 +0000) |
| EMAâs Perspective on the Future of Medicines Regulations |
| This article talks about the EMA’s perspective on the future of medicines regulations. The prime goal of a Health Authority (HA) is to promote and protect the interests of those it serves by amending and introducing new regulations. The European Medicines Regulatory Network (EMRN) is a network of |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 30 Jun 2022 07:13:15 +0000) |
| Steps for the pharmaceutical organizations for successful regulatory submissions |
| This article talks about the measures that pharmaceutical organizations must take for successful regulatory submissions. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 30 Jun 2022 07:12:43 +0000) |
| EMA's Pharmacovigilance Activities to identify an alert signal |
| This article talks about the trigger for EMA's Pharmacovigilance Activities to identify an alert signal. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 30 Jun 2022 07:12:03 +0000) |
| South Koreaâs UDI Compliance Requirements for Medical Device Registrations |
| This article talks about the South Korea’s UDI compliance requirements for Medical Device registrations. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 20 Jun 2022 05:25:34 +0000) |
| Quality by Design QbD- An Enhanced Route for Drug Development |
| Over the decades, advancements in treatment procedures have brought about necessary amendments to the Regulatory framework. From Active Pharmaceutical Ingredient (API) identification to its placement on the patient’s side table, the core of innovating novel treatment protocols revolves around thre |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 20 Jun 2022 05:24:49 +0000) |
| Optimizing Regulatory Submissions with Structured Content and Data Management SCDM |
| Pharmaceutical companies incur about 25% of drug development costs into the documentation. Strategic imperatives can help accelerate the drug development pipeline along with scrutiny of clinical and Regulatory content, enabling efficient reuse of more standardized content. Identifying gaps associate |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 07 Jun 2022 10:10:16 +0000) |
| Top 15 Frequently Asked Questions FAQs on US Agent |
| The US is the largest medical device market, worth USD 180 billion (2021) and is expected to reach USD 670 billion at a CAGR of 5.2% from 2022 to 2027. The global medical device manufacturers find it promising to get their devices approved by US FDA and subsequently export them to the US. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 07 Jun 2022 10:09:41 +0000) |
| Comparative Analysis of Dossier Submissions in Europe EU& United States US Market |
| Over the past ten (10) years, the cost of bringing a drug into the market has increased by 140 percent. Globally, the top twenty (20) pharmaceutical organizations spend nearly sixty (60) billion dollars every year to bring a drug into the market and the average cost is estimated to be $2.6 billion, |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 20 Apr 2022 12:44:47 +0000) |
| FSSAIâs 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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 20 Apr 2022 12:06:11 +0000) |
| HPRAâs Perspective on multilingual labeling |
| This article talks about the Health Products Regulatory Authority's (HPRA) Perspective on Multilingual Labeling. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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). |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 14:50:17 +0000) |
| USFDAâs 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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Mar 2022 11:44:15 +0000) |
| ECsâ 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). |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Mar 2022 11:42:42 +0000) |
| Health Canadaâs 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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Mar 2022 11:42:04 +0000) |
| MHRAâs 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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Feb 2022 09:33:18 +0000) |
| Comparative Analysis of TGAâs 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 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Feb 2022 09:32:27 +0000) |
| Obligations of Economic Operators EOs under the Swissmedicâs 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 ( |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Feb 2022 09:31:32 +0000) |
| FDAâs 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. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (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. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Feb 2022 09:30:11 +0000) |
| EMAâs 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. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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