GMP News - Regulatory Affairs

24.02.22

ANVISA: Version 2 of the CADIFA Manual for APIs available

The second version of the "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) was published in June 2021 and needs to be followed for API dossiers.

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17.02.22

How to handle Expiry Dates under the CTR

The reflection paper on the use of interactive response technologies (IRT) has been updated in view of the entry into application of the EU Clinical Trials Regulation (CTR) on 31 January 2022. It clarifies that the removal of expiry dates from the labels is not allowed for clinical trials conducted under the CTR.

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17.02.22

PIC/S revises GMP guide to reflect EU Clinical Trials Regulation

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its GMP guide to reflect the EU Clinical Trials Regulation, which became applicable on 31 January 2022. In addition, a new PIC/S Annex 16 on the certification by the authorized person and batch release has been included.

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17.02.22

Final EMA Guidelines on Quality Requirements for IMPs

The final EMA Guidelines on the quality requirements for IMPs (pharmaceutical and biopharmaceutical drugs) have been released on the EMA website together with an overview of comments received on the draft guidelines published last year. Many of the comments related to the question "What is a Non-substantial Modification?".

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16.02.22

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

In February 2022, the EMA published on its website the updated and revised versions of the "Questions & Answers (Q&A)" documents related to centralised marketing authorisation procedures.

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09.02.22

CMDh/HMA: Update of the Q&A List on Variations

A new version of the "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" was created in December 2021 and published on the HMA (Heads of Medicines Agencies) website.

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09.02.22

EU: Strengthening the EMA

A regulation strengthening the role of the EMA in crisis preparedness and management has been published in the Official Journal of the EU. The document also assigns several new tasks to the EMA.

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27.01.22

EMA publishes Guidance on Companion Diagnostics

As May 2022 approaches, the need for guidance on the In Vitro Diagnostics Regulation (IVDR) is growing. Regarding the topic of companion diagnostics, the EMA published a draft document at the end of last year about the consultation procedure between the EMA and a Notified Body.

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26.01.22

FDA: Delays in Resumption of Inspections

The FDA announced that the agency is adjusting its planned inspection activities to the spread of the Omicron variant and has therefore temporarily postponed certain inspection activities.

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26.01.22

Nitrosamines in Herbal Medicinal Products?

The EMA HMPC has prepared a new question and answer on herbal medicinal products, which has been included in the practical guidance for marketing authorization holders on the subject of contamination by nitrosamines. Does a nitrosamine risk assessment also have to be carried out for herbal medicinal products?

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26.01.22

Update of the CMDh's Q&A Document on Nitrosamine Impurities

Marketing authorisation holders of medicinal products that contain sartan or sartan derivatives as active ingredients are required to submit the results of the review of their products under the "Call for Review" via variation applications. Find out what requirements must be met in this regard in the CMDh's recently updated Q&A document.

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25.01.22

EMA: Draft Guidance for Centralised Procedures open for Comments

In December 2021, the European Medicines Agency (EMA) published the draft guideline "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure" for public comment on their website. 

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25.01.22

Version 4.1 of the Q&As regarding the Clinical Trials Regulation

The European Commission published an updated version of the Questions & Answers document relating to the Clinical Trials Regulation (EU) No 536/2014. What documentation is required in the application for the authorization of a clinical trial relating to GMP for IMPs?

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25.01.22

Pharmacovigilance Inspections Report

The MHRA GVP inspectorate recently published the latest inspection metrics for the period from April 2020 to March 2021. All inspections in this period were conducted remotely. The largest number of findings in the reporting period related to quality management systems, followed by risk management, and ongoing safety evaluation.

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25.01.22

Safety Assessment of Clinical Trials

To ensure effective and efficient safety assessment of clinical trials, the EU Commission published rules and procedures for the cooperation of the Member States. The new Regulation will become applicable on 31 January 2022 - together with the Clinical Trials Regulation (EU) No 536/2014.

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