GMP News Drug Safety/Pharmacovigilance

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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02.05.19

FDA´s new Steps regarding Voluntary Recalls

The US Food & Drug Administration (FDA) has recently issued a new draft guidance on the initiation of voluntary recalls.

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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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20.02.19

Final FDA Guidance on Public Warning and Notification of Recalls

The FDA strengthens the process for issuing a public warning about a voluntary recall and for notification of recalls. Read more about FDA´s final guidance on Public Warning and Notification of Recalls.

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16.01.19

New ISO Standard for Tamper-Evident Packaging

The International Organization for Standardization has published the new ISO standard "Packaging - Tamper verification features for medicinal product packaging".

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04.10.18

EMA clarification on the download of SARs from EudraVigilance

Due to inquiries concerning the handling of ICRs in EudraVigilance, the EMA has published a brief and structured clarification.

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04.10.18

What to expect from GVP inspections?

The MHRA recently updated their Good Pharmacovigilance Practice (GVP) webpage on the MHRA website. In addition, the agency provided important things to know about GVP inspectors and GVP inspections.

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