GMP News - Regulatory Affairs

27.07.22

Swissmedic´s New Website for Herbal Medicinal Products

The Swissmedic website for authorization of herbal medicinal products (HMPs) has been completely revised and updated. It provides information on simplified authorization procedures for HMPs, e.g. for "HMPs with known active substance".

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21.07.22

EMA updates eAFs for Variations for Medicinal Products for Human and Veterinary Use

The electronic application forms for submission of variations (eAFs) for medicinal products for human and veterinary use were updated in June and are listed in the latest versions on EMA's eSubmission website.

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21.07.22

EDQM: European Pharmacopoeia Version 11 published

The 11th version of the European Pharmacopoeia (Ph.Eur.) is now available. The latest edition includes some updated monographs which will be implemented on 01 January 2023.

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21.07.22

The latest Updates of the EMA's Question and Answer Document on Nitrosamine Contamination

The EMA and CMDh question and answer collection on nitrosamine impurities in APIs and medicinal products is a "living" document that is updated at irregular but short notice intervals. You can find out here which current requirements and changes with regard to nitrosamine impurity limits, risk assessments and reporting obligations are important for marketing authorisation holders.

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13.07.22

What is an FDA-Approved Product?

The FDA posted an article on the ways the FDA is regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food, and cosmetics. How can you know for sure that a product is FDA-approved?

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13.07.22

GMP vs GACP: BfArM Makes some Clarifications

The German BfArM now clarified for medical Cannabis Manufacturers: A valid GMP certificate must be included with the drying step.

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06.07.22

Authorities test Hybrid Inspections

A pilot project will be launched under the auspices of ICMRA to conduct hybrid inspections at facilities of applicants.

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30.06.22

Benefit-Risk Assessment for Product Quality Evaluation

Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.

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29.06.22

EMA: Another Update of the "IRIS" Documents

Since May 2022, the new version of the "IRIS guide for applicants" is available on the EMA website. Besides formal adaptations, version 2.10 contains additions in chapter 7 and updates in chapters 2 and 6.

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22.06.22

EMA: Another Update of the Q&As on Parallel Distribution

Already in April 2022, the "Frequently asked questions about parallel distribution" were revised and published on the EMA website - as already reported recently. Now, the Q&As have been updated again and supplemented.

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21.06.22

What is a Complex Clinical Trial?

In order to support sponsors, clinical investigators and applicants in planning and conducting complex clinical trials (CCTs), a new Q&A document covering this topic has now been published on the European Commission (EC) website. What is a complex clinical trial?

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21.06.22

Clinical Trials Regulation - Version 6.1 of the Q&As

The European Commission published an updated version of the Questions & Answers document relating to the EU Clinical Trials Regulation. What are the GMP consequences of switching the regulatory framework applicable to a clinical trial?

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08.06.22

USP intends to revise the Chapters on Microbiological Control of Non-sterile Medicinal Products

In PF46(2), the United States Pharmacopoeia has published a Stimuli article addressing the planned revision of chapters relevant to microbiological control of non-sterile products.

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25.05.22

EMA Publishes Final Guidelines on Quality and Specifications for HMPs

The EMA published the final guidelines (Revision 3) on quality and specifications for herbal medicinal products (HMPs). Amongst others, a written GACP confirmation for the herbal substance should be provided.

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18.05.22

Data Protection of Information Uploaded in the CTIS

To assist sponsors and authorities in fulfilling the transparency requirements set out in the Clinical Trials Regulation, the EMA is preparing a dedicated guidance on the protection of personal data in the CTIS. The agency has published a public consultation document to allow for wider stakeholder input.

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