GMP News - Regulatory Affairs

01.07.21

EMA publishes Q&A Document about Parallel Distribution

Parallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing-authorisation holder. In this context, the European Medicines Agency (EMA) has recently published a new comprehensive Q&A document containing answers to the most common questions.

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09.06.21

Herbal Drugs - What is Well-Established Use?

Herbal medicinal products can be registered via the well established use approach within the EU. But what is needed for the simplified registration and how to demonstrate well established use?

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09.06.21

US Implementation of ICH Q12

The US FDA recently issued a draft guidance to help manufacturers implement ICH Q12 by explaining how to submit ECs. In addition, the agency provides general guidance about the elements that are considered ECs for the device constituent part of combination products.

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26.05.21

APIC: Update of the Template for Potential Nitrosamine Contaminations

The latest version of the "REPORT ON THE RISK OF POTENTIAL PRESENCE OF NITROSAMINE IMPURITIES" has been available on the APIC website since April 2021. The questionnaire is to be seen as a summary report and can be used to document the results of the risk assessments with regard to contamination by nitrosamines in APIs.

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26.05.21

FDA adopts ICH Q12

The FDA adopted the ICH Q12 Guideline for post-approval change management. The guideline is intended to complement the existing ICH Q8 to Q11 Guidelines. It is composed of a Core Guideline and two Annexes with practical examples for ECs and PACMPs.

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14.04.21

Illegal Selling of CBD-Products: FDA Continues Issuing Warning letters

The FDA still warns companies for illegal selling Over-the-Counter CBD Products for pain relief including products listing CBD as an inactive ingredient.

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07.04.21

EMA: Revision of Q&A Documents regarding the Centralised Procedure

The latest versions of the two Q&A documents relating to the centralised procedure have each been supplemented by a question regarding the importation of finished medicinal products into the European Union.

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30.03.21

Post-Authorization Safety Studies - Recent Inspection Findings

The MHRA recently published inspection findings in the conduct of post-authorization safety studies (PASS). In particular, the agency observed significant breaches of the study protocol for the MAHs non-interventional PASS during inspection at a study site.

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30.03.21

How to Classify Changes to Ongoing Clinical Trials

The European Commission published an updated Version 3 of the Questions & Answers relating to the Clinical Trials Regulation. Amongst others, the new version covers the classification of changes to ongoing clinical trials.

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30.03.21

Reference Safety Information in Clinical Trials

The MHRA GCP inspectorate has continued to see non-compliance in reference safety information in clinical trials. In particular, the agency is still seeing unreported SUSARs and absence of adequate risk mitigation measures due to incorrect use of the RSI.

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24.03.21

Cannabis Glossary and GACP Revision

EMA´s Committee on Herbal Medicinal Products published the 2021 HMPC Work plan. Amongst others the HMPC plans to establish a Cannabis glossary and to revise the GACP guidelines.

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24.03.21

Sartan Medicinal Products: EMA's Assesment Report defines Nitrosamine Limits and Reporting Deadlines

In a final assessment report, the CHMP has published recommendations for marketing authorisation holders of medicinal products containing sartan. Read more here about the requirements for limit values of nitrosamine impurities and for risk assessments, as well as the deadlines to be met.

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23.03.21

Pharmacovigilance Inspection Metrics

The MHRA GVP inspectorate recently published their latest inspection metrics for the period from April 2019 to March 2020. The highest number of all findings in the reporting period related to risk management followed by quality management systems.

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23.03.21

Brexit: Pharmacovigilance Requirements for UK MAHs

The MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders.

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11.03.21

New FDA Guidance for COVID-19 Packaging Changes: Glass Vials and Stoppers

COVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers) due to supply chain issues affecting their availability. Therefore, the FDA has issued a new guidance with recommendations for the appropriate reporting category and the content of postapproval change submissions.

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