GMP News - Regulatory Affairs

18.03.24

EMA/CMDh: Appendix 1 for Nitrosamines Updated Again

The nitrosamine Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh contains three annexes (Appendix 1-3) in its current version of October 2023. In February 2024, Appendix 1 was updated again and fifteen new substances were added.

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14.03.24

EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications

The FDA and the European Medicines Agency (EMA) published "EMA–FDA joint Q&As on Quality and GMP aspects" supporting quality development for FDA’s Breakthrough Therapy (BT) and EMA's Priority Medicines (PRIME) programs.

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14.03.24

Improving Registration and Reporting Summary Results Information for Clinical Trials

The FDA is announcing a newly published report on the Clinical Trials Transformation Initiative (CTTI) prepared on the findings of a collaborative project with FDA to understand the barriers to timely, accurate and complete registration and reporting of summary results information for clinical trials. According to the report, the major challenge was a lack of understanding on the part of the Responsible Party regarding the types of trials that must be registered, when the trial should be registered and when and for which trials summary results information must be submitted.

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14.03.24

Master Protocols for Drug and Biological Product Development

A new FDA guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on the submission of documentation to support regulatory review. Commenting on the proposed guideline was open until 22 February 2024.

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13.03.24

APIs in Brazil: how to register and obtain the GMP certificate

In February 2024, the ECA offered the Live Online Training "How to register APIs in Brazil - Focus on CADIFA and obtaining a Brazilian GMP certificate". During the Q&A sessions, many interesting questions were posed to the speakers' team. A list of useful abbreviations and definitions in regard on the Brazilian registration system are collected and provided in the following.

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13.03.24

EDQM: Top Ten Deficiencies for CEPs

In February 2024, the EDQM has published its summary of the top ten deficiencies which occurred during the evaluations of the CEPs in 2023. This document called "TOP TEN DEFICIENCIES in New Applications for Certificates of Suitability for chemical purity" should help applicants to avoid such deficiencies in future and lists in detail the findings and its respective sections.

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06.03.24

EMA/CHMP/CVMP: New Q&A document for the Use of CEPs

In the middle of February, the document "QWP Questions and Answers (Q&A): how to use a CEP in the context of a Marketing Authorization Application (MAA) or a Marketing Authorization Variation (MAV)" prepared by the EMA, the CHMP (Committee for Medicinal Products for Human Use) and the CVMP (Committee for Medicinal Products for Veterinary use) was published on the EMA website for the first time.

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28.02.24

FDA Guideline "Advanced Manufacturing Technologies Program" published as a Draft

The FDA defines advanced manufacturing as innovative pharmaceutical manufacturing technologies or an approach with the potential to improve the reliability and robustness of the manufacturing and supply chain. The FDA encourages the early adoption of such advanced manufacturing technologies and has established a programme for this purpose.

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21.02.24

What is the African Medicines Agency?

The EMA has received a grant of ten million euros from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA).

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21.02.24

EMA/HMA/ECA: List of Active Substances defined to prevent supply bottlenecks

As part of the measurements against supply shortages in the pharmaceutical sector, the first version of the "Union list of critical medicines" and further information on this was published on the EMA website at the end of last year. This list contains more than 200 active substances that are considered critical in the event of a supply shortage and whose shortage must be avoided at all costs.

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21.02.24

Swissmedic: Nitrosamine Requirements updated

Swissmedic's nitrosamine Q&A document "Update of the requirements for dealing with nitrosamine impurities in medicinal products" was updated in January 2024 and is now available in the new version on the Swissmedic website.

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13.02.24

EMA: Further Update of the Q&A Documents on "Centralised Procedures"

In December 2023, the Questions & Answers (Q&A) documents related to centralised procedures were revised again and published on the European Medicines Agency (EMA) website. The list of Q&As, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to any questions that may arise at different stages of the centralised marketing authorisation application.

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13.02.24

EMA: FAQs for the Use of IRIS

In January, the question and answer catalogue "RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) - Frequently Asked Questions and Answers" was published on the EMA website. In addition to the glossary, it contains 23 questions and their answers relating to the use of the IRIS system.

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13.02.24

EDQM: Addendum 11.5 to the European Pharmacopoeia available

The Supplement 11.5 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 01 July 2024. All CEP holders are required to harmonise their specifications and thus the respective CEPs with the new monographs.

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08.02.24

FDA Revision to the Guidance on Quality Considerations for Ophthalmic Drug Products

Following recent cases of microbially contaminated ophthalmic drug products as well as safety recalls, the FDA published a revised draft guidance on Quality Attributes for Ophthalmic Drug Products, to include information about product sterility and preservative use. Moreover the revision clarifies that the guidance applies to all ophthalmic drugs, including over-the-counter (OTC) drugs and combination products.

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