GMP News Drug Safety/Pharmacovigilance

21.08.19

What is a Combination Product?

The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).

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24.07.19

French pilot programme for medical cannabis

The objective of the French pilot programme is to follow the recommendations of the CSST to evaluate cannabis prescribing and dispensing, and to collect safety and efficacy data. However, medical cannabis is not expected to be legalized in France prior to the end of 2021.

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17.07.19

New Zealand proposes new legislation for medical cannabis

New Zealand released a proposed regulatory approach for medical cannabis. The implementation of the medical cannabis program is anticipated to start in the first quarter of 2020. In addition, the document proposes two options for GMP.

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10.07.19

Canada´s New Regulatory Approach for Cannabis Products

Health Canada proposes a regulatory pathway for a new class of cannabis products referred to as Cannabis Health Products that would not require practitioner oversight.

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12.06.19

German Pharmacopoeia Draft Monograph for Cannabis Extracts

A draft for a new German Pharmacopoeia monograph entitled "Cannabis Extract, Standardized (Cannabis extractum normatum)" has been published in the (German) Bundesanzeiger.

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05.06.19

Cannabis - BfArM awards remaining contracts

The time has come for Cannabis "Made in Germany". The German Federal Institute for Drugs and Medical Devices (BfArM) has completed the award procedure for the cultivation of cannabis.

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28.05.19

EMA's Annual Report on the EudraVigilance Database

The EMA has published the Annual Report 2018 on EudraVigilance summarizing the current status of the database.

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28.05.19

How to manage Safety Data in a blinded Trial?

The MHRA Inspectorate recently clarified the agency´s expectations regarding the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs.

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28.05.19

FDA´s final REMS Guideline

The US FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy (REMS) plans and to making sure they do not impede generic drug development.

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10.04.19

FDA establishes a working group on cannabis and cannabis-derived products

There is currently a growing interest in the development of therapies derived from cannabis and its components.The FDA recently announced to form an internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD.

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03.04.19

Brexit: MHRA clarifies UK PV rules for the no-deal scenario

The MHRA recently published guidance on QPPVs, PSMFs and MHRA PV registration in the event of a no-deal Brexit.

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03.04.19

GMP for Cannabis - What is required?

More and more countries allow cannabis for medicinal purposes - But what are the regulatory requirements?

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20.03.19

Focus on Cannabis in INCB´s Report for 2018

The International Narcotics Control Board (INCB) recently published its report for 2018 with a strong focus on cannabis. Read more about Cannabis and cannabinoids for medical, scientific and “recreational” use: risks and benefits.

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06.03.19

WHO Recommends Re-Classification of Cannabis

After the legal situation for medical cannabis in Germany has already changed in 2017, the World Health Organization (WHO) has now proposed a global re-classification of the addictive potential of cannabis.

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26.02.19

MHRA Pharmacovigilance Inspection Metrics

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2017 to March 2018. 

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