03 August, 2018

Regulatory trends: your list of pharmaceutical regulatory affairs changes

By Andrea Sisneros

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Each month, Envigo's pharmaceutical regulatory experts review the changes and influences affecting drug development around the world. Dive into some useful resources to ensure you stay in the know about regulatory affairs.

November 2018 

World Health Organization (WHO)

The International Council for Harmonisation (ICH)

Heads of Medicines Agencies (HMA)

European Medicines Agency (EMA)

 News:

 Regulatory and procedural guidelines:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Food and Drug Administration (FDA)

 Guidance for industry:

Center for Biologics Research and Evaluation (CBER)

European Directorate for the Quality of Medicines (EDQM)

October 2018 

World Health Organization (WHO)

European Medicines Agency (EMA)

 News:

 Regulatory and procedural guidelines:

 Templates:

Questions and answers:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Food and Drug Administration (FDA)

 Guidance for industry:

Center for Biologics Research and Evaluation (CBER)

September 2018

World Health Organization (WHO)

The International Council for Harmonisation (ICH)

Heads Of Medicines Agencies (HMA)

European Medicines Agency (EMA)

 News:

 Regulatory and procedural guidelines:

 Questions and answers:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Food and Drug Administration (FDA)

 Guidance for industry:

Center for Biologics Research and Evaluation (CBER)

August 2018

World Health Organization (WHO)

Heads of Medicines Agencies (HMA)

European Medicines Agency (EMA)

 News:

 Regulatory and procedural guidelines:

 Questions and answers:

EUDRALEX

Medicines and Healthcare Products Regulatory Agency (MHRA)

Food and Drug Administration (FDA)

 Guidance for industry:

Center for Biologics Research and Evaluation (CBER)

July 2018

World Health Organization (WHO)

International Council for Harmonization (ICH)

Heads of Medicines Agencies (HMA)

European Medicines Agency (EMA)
Presentations:

 News:

Regulatory and procedural guidelines:

Questions and answers:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Food and Drug Administration (FDA)

Guidance for industry:

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Category // Pharmaceutical development, Regulatory affairs, European Medicines Agency, Food and drug administration