GMP News - Regulatory Affairs

29.07.20

ASMF: Two API Manufacturing Sites Listed - Only One to Be Registered?

This is now also possible for ASMFs and the procedure is clearly described in the updated Q&A document of the CMDh.

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22.07.20

Pharmacovigilance Audits and Inspections during COVID-19

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes new Q&As relating to pharmacovigilance activities like CAPAs, Audits and Remote-Inspections.

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16.07.20

FDA offers online courses for the pharmaceutical industry

The FDA offers diverse online material as part of their CDERLearn Training and Education Program. A special section contains courses for the pharmaceutical industry.

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16.07.20

Covid-19: Handling of Marketing Authorisations

In order to ensure a smooth and efficient cooperation between the authorities and marketing authorisation holders even in the times of Covid-19, the documentation and templates to facilitate the handling of marketing authorisations have now been bundled, listed and published on the website of the HMA (Heads of Medicines Agencies).

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16.07.20

New Version of the Q&A Catalogue published

In July, new topics were added to the question and answer catalogue "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC".

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08.07.20

Pharmacist as new EMA Executive Director

Emer Cooke from Ireland will be the new director of the European Medicines Agency (EMA) in Amsterdam. This was announced by the EMA Management Board.

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02.07.20

Is an Update of the QPPV´s Contact Details a Variation?

The CMDh and CMDv recently published a revised version of the Q&A paper regarding variations including a new question on how to notify about an update of the QPPV´s contact details.

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18.06.20

CEPs: What Applicants and Authorisation Holders should know!

Due to the corona pandemic, many processes and regulations are currently in change - information regarding the current procedures for applying for CEPs is listed on the EDQM website.

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18.06.20

CMDh: Update of the Q&A List Variations

The Q&A document on variations entitled "Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008" of the CMDh and CMDv was updated again in May 2020.

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18.06.20

Q&A paper of EMA, EC and HMA updated once again

Again, the catalogue with "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC" issued by the EC, HMA and EMA has been updated. It now includes the facilitated handling of existing marketing authorisations together with the handling of marketing authorisation procedures in times of Covid-19.

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16.06.20

MHRA´s Pharmacovigilance Inspection Metrics

The MHRA GVP inspectorate recently published their latest pharmacovigilance inspection metrics report. The report includes remote inspections and lists critical findings in relation to risk management, the quality management system and the provision of information for inspections.

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16.06.20

Follow-up activities after Pharmacovigilance Inspections

EMA´s Pharmacovigilance Inspectors Working Group adopted an new guideline on the follow-up activities of pharmacovigilance inspections.

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02.06.20

MHRA´s Expectations during GCP Inspections

The MHRA recently shared their expectations regarding electronic systems used in clinical trials and what they want to see during a GCP inspection.

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20.05.20

What Marketing Authorisation Holders need to know now about their Registrations

On 10 April 2020, the European Medicines Agency (EMA) together with the Heads of Medicines Agencies (HMA) and the European Commission (EC) published a first version of the document "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", which is continuously updated and adapted.

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13.05.20

USP´s Quality Considerations for Medical Cannabis

The USP Cannabis Expert Panel has published an article on the quality requirements for medical cannabis in the Journal of Natural Products. The article describes the appropriate use of USP General Chapters related to chromatographic methods and controls for contaminants.

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