GMP News Drug Safety/Pharmacovigilance

22.08.18

EMA publishes list of contact details for pharmacovigilance enquiries

The EMA published information extracted from the Article 57 database (xEVMPD) in the form of an Excel document. The file contains a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries.

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11.07.18

FDA Drafts on Shared System REMS

The FDA published two new draft guidelines on Risk Evaluation and Mitigation Strategy (REMS) for sponsors of clinical trials. Read more about the draft documents on developing a shared system REMS, and waivers associated with the single, shared system REMS requirement.

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13.06.18

FDA opens Docket on Software Products

The U.S. Food and Drug Administration, FDA, recently opened a docket on specific types of software, including general wellness software products, electronic patient records and more.

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07.02.18

Effect of the new Annex 13 on Complaints and Recalls

The final "Detailed Commission guidelines on GMP for IMPs for human use" have been published in Annex 13 of the EU GMP-Guidelines. What has changed in comparison to the previous Annex 13 in regard to complaints and recalls?

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29.01.18

Effect of the new Annex 13 on Labelling of IMPs

The final "Detailed Commission guidelines on GMP for IMPs for human use" have been published in Annex 13 of the EU GMP-Guidelines. What has changed in comparison to the previous Annex 13 with regard to IMP labelling?

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24.01.18

PSURs: EMA revises Post-Authorization Procedural Advice

The EMA recently revised its post-authorization procedural advice for users of the centralized procedure. Read more about new and revised Q&A´s concerning Periodic Safety Update Reports (PSURs).  

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06.12.17

Drug Safety: FDA´s new Draft Guidance Regarding REMS

The FDA recently published its new draft guidance on Risk Evaluation and Mitigation Strategy (REMS). Read more about Format and Content of a REMS Document.

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22.11.17

GVP Update 2017

There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more about the revisions of several GVP Modules and the published draft of Product- or Population-Specific Considerations IV: Paediatric population.

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