GMP News - Regulatory Affairs

11.03.21

COVID-19 Vaccines, Tests and Therapeutics - Recommendations for Handling Emerging Virus Variants

The new variants of SARS-CoV-2 are now occupying the minds of scientists around the world. The FDA is responding with a series of updated guidelines and recommendations for developers and manufacturers of vaccine tests and therapeutics.

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04.03.21

EMA Guidance on Adjusting Vaccines to COVID-19 Variants

Authorisation requirements for adjusted COVID-19 vaccines: the EMA publishes recommendations for vaccine developers and manufacturers.

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17.02.21

EMA Clarifies GMP Requirements for Herbal Substances Used as APIs

When does EU GMP Guide Part II apply to the manufacture of herbal extracts? A new EMA Q&A document on GMP for herbal extracts used as active substances in herbal medicinal products gives the answer to this question.

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17.02.21

FDA Applications during Covid-19: better Communication planned

With an updated Guidance document, the US Food and Drug Administration (FDA) plans to improve communication with industry.

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17.02.21

EMA: Revised Q&A Document for Centralised Procedures

The "Q&A" document for centralised marketing authorisation procedures, focusing on questions and answers on topics that marketing authorisation holders should consider after obtaining a marketing authorisation, was revised again and published on the EMA website in February.

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16.02.21

Updated Guidance on the Management of Clinical Trials during COVID-19

Pragmatic procedures are currently required to ensure the flexibility needed to maintain the integrity of clinical trials during the COVID-19 pandemic. The updated guidance on management of clinical trials during COVID-19 includes adapted approaches for IMP supply and details on remote source data verification.

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16.02.21

Updated Timeline for the Clinical Trial Regulation

The EMA is still planning with January 2022 as the date for the first application of the Clinical Trial Regulation (CTR). Initial information on the schedule was published in December.

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04.02.21

Modern Vaccines and Platform Technologies - Explained in an Understandable Way

Questions reaching us on the subject of COVID-19 vaccines, their development, approval and production, and on modern platform technologies used are answered in a summary.

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20.01.21

EMA: Updated Q&A documents on Centralised Procedures

The "Q&A" documents for centralised procedures were revised and published on the EMA website in January. In general, pre- and post-approval advices regarding centralised procedures are given and specially information for applicants of generic or hybrid medicinal products is mentioned. 

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13.01.21

Brexit Agreement - what now?

Brexit: The agreement on the future relationship between the European Union and the United Kingdom is here. What are the consequences for medicinal products?

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09.12.20

UN Commission Reclassifies Cannabis

The United Nations (UN) Commission on Narcotic Drugs (CND) has decided to reclassify cannabis. With this, the Commission followed the WHO recommendation of 2019.

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08.12.20

FDA - Notification of Deviations in Cell and Tissue Products

An FDA document on Biological Product Deviation refers to products based on human tissues or cells.

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08.12.20

FDA explains Background of Emergency Use Authorizations related to COVID-19 Vaccines

Recently, the FDA published a Q&A Paper on their website that answers the most common questions about the emergency approval of COVID-19 vaccines and explains the underlying process.

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02.12.20

Will CBD be Controlled as a Narcotic?

Will Cannabidiol be controlled as a narcotic in the future? This question is currently intensively discussed. The European Court of Justice recently released their opinion.

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25.11.20

EMA - Public Meeting on COVID-19 Vaccines

Due to the great public interest and the varied discussions, EMA organises a public meeting on Covid-19 vaccines and the role of EMA in the approval process, which all interested citizens can attend via live broadcast.

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