GMP News - Regulatory Affairs

The International Council for Harmonization (ICH) recently published a new reflection paper on "Further Opportunities for Harmonization of Standards for Generic Drugs".

The EMA recently released comments gathered during its public consultation for the ICH Q12 draft guideline. Read more about EMA ´s overview of comments received on ICH Q12 on pharmaceutical product lifecycle management.

A new post, "Is it really a First in Human trial? Categorizing and assessing the risks correctly" has just been published on the MHRA Inspectorate blog.

The Swiss authority Swissmedic has published a new auxiliary document for the so-called "RP Declaration".

EMA has published a strategic reflection paper "EMA Regulatory Science to 2025". As a consequence, the regulatory landscape, including GMP requirements and standards, needs to be adapted.

A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH M11 guideline Clinical electronic Structured Harmonized Protocol (CeSHarP).

End of September the EMA together with the European Commission organised a meeting with industry stakeholders to discuss the UK's withdrawal from the European Union ("Brexit"). Now the report of the EMA-Industry stakeholder meeting was published.