"Advance Therapy Medicinal Products (ATMPs) are novel drugs that meet patientsā specific needs. But they drastically increase the cost of treatment. Generic alternatives provide relief in terms of treatment cost with a quality drug of similar effectiveness.
A complex generic product is generally similar to brand-name generics. However, there are differences between the two (02) in manufacturing and quality control procedures. An innovator molecule may have critical procedures that govern the nature of the molecule. Critical parameters of a molecule may make it difficult to replicate while developing a generic version of the medication. In such cases, Standard Operating Procedures (SOPs) will help meet the optimal requirements for the molecule while developing complex generic products for in-vitro studies, in-vivo studies, and drug product quality testing. To facilitate the entry of generic alternatives in such therapeutic area
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Highlights of the Self-Testing Provision for Medical Devices in China