Mfg News: European Medicines Agency & FDA
A roundup of manufacturing news from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Highlights below.
* EMA Issues Draft Guideline on Development, Manufacturing of Oligonucleotide Drugs
* FDA Issues Draft Guidance on Post-Approval Mfg Changes for Biosimilars
* FDA Issues Warning Letters to Two China-based Manufacturers of Syringes: Updates Advisement of Syringes Made in China
EMA Issues Draft Guideline on Development, Manufacturing of Oligonucleotide Drugs
The European Medicines Agency (EMA) has issued a draft guideline to set out the type of information required for the development, manufacture, and control of synthetic oligonucleotides (existing or new chemical entities) used in a medicinal products for purposes of obtaining a marketing authorization. The draft guideline addresses specific aspects regarding the manufacturing process, characterization, specifications and analytical control for synthetic oligonucleotides that are not covered in the EMA’s Guideline on the Chemistry of Active Substances (EMA/454576/2016) or Chemistry of Active Substances for Veterinary Medicinal Products.
The draft guideline addresses specific aspects regarding the manufacturing process, characterization, specifications and analytical control for synthetic oligonucleotides. It also contains requirements and considerations related to conjugation, active substance in solution, medicinal product development, oligonucleotide generics development, oligonucleotide personalized medicine approaches, and clinical trial applications (human products only).
The deadline for submitting comments on the draft guideline is January 31, 2025.
Source: European Medicines Agency
FDA Issues Draft Guidance on Post-Approval Mfg Changes for Biosimilars
The US Food and Drug Administration (FDA) has issued draft guidance to provide answers to commonly asked questions from applicants and other interested parties regarding post-approval manufacturing changes made to licensed biosimilars and licensed interchangeable biosimilars. The draft guidance is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories. Comments are due by September 23, 2024.
Source: US Food and Drug Administration
FDA Issues Warning Letters to Two China-based Manufacturers of Syringes; Updates Advisement of Syringes Made in China
The US Food and Drug Administration (FDA) has issued an additional Warning Letter to Jiangsu Shenli Medical Production, a Changzhou, Jiangsu, China-based medical-device company, for quality system violations for its syringe products. FDA had previously issued a Warning Letter in March 2024 to Jiangsu Shenli Medical Production for violations regarding plastic syringes. As a result, Jiangsu Shenli Medical Production’s previous import alert was expanded to prevent its enteral syringes from entering the US.
FDA also issued a Warning Letter to Jiangsu Caina Medical, a Zhutang, Jiangsu, China-based medical-device company, for quality system violations.
In November 2023, the FDA advised consumers, healthcare providers, and healthcare facilities that it was evaluating the potential for device failures (such as leaks, breakage, and other problems) with certain plastic syringes manufactured in China, which are used for injecting fluids into, or withdrawing fluids from, the body.
Until further notice and because of potential quality and performance issues, FDA is advising as of July 18, 2024, to immediately transition away from using plastic syringes manufactured by the following China-based manufacturers, unless use of these syringes is absolutely necessary until a transition to syringes that are not manufactured in China is completed: Jiangsu Caina Medical Co., Ltd., Jiangsu Shenli Medical Production Co., Ltd., Shanghai Kindly Enterprise Development Group Co., Ltd., and Zhejiang Longde Pharmaceutical Co., Ltd.
FDA is also advising as of July 18, 2024, to immediately transition away from using enteral syringes manufactured by Jiangsu Shenli Medical Production Co., Ltd. unless use of these syringes is absolutely necessary until a transition to enteral syringes manufactured by a different manufacturer is completed.
The FDA is not recommending a transition away from all enteral syringes manufactured in China at this time (as of July 18, 2024). For all other plastic syringes made in China while the FDA’s evaluation remains ongoing, the agency continues to recommend the following: (1) check the manufacturing location for syringes in use or in inventory by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization; (2) use syringes not manufactured in China, if possible; at this time, glass syringes, pre-filled syringes, or syringes used for topical purposes are not included in the agency’s advisement; and (3) if a company only has syringes manufactured in China, then continue to use them as needed until able to use alternative syringes and closely monitor for leaks, breakage, and other problems.
Source: US Food and Drug Administration
