GMP News Drug Safety/Pharmacovigilance

06.10.22

List of Documents Needed during GVP Inspections

The EMA published a guidance for applicants / MAHs involved in GVP inspections. It includes a detailed list of documents to be provided to GVP inspectors.

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06.10.22

FDA´s Implementation Guide for ICH E2B (R3)

The FDA released a technical specifications document to assist interested parties in electronically submitting ICSRs to the agency. Read more about FDA´s regional ICH E2B (R3) Implementation Guideline.

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28.09.22

EMA: New Update of the "IRIS" Documents

In September 2022, the documents "IRIS guide for applicants" and "IRIS guide to registration and RPIs" were updated again - now containing some innovations and revisions.

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20.09.22

Charging for IMPs? FDA has some Answers

The FDA issued a revised Q&A document on charging for investigational medicinal products (IMPs). The draft guidance responds to frequently asked questions about FDA's processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances.  

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20.09.22

FDA publishes Answers to GCP Questions

The FDA addresses inquiries from stakeholders related to Good Clinical Practice on an ongoing basis and has now published responses to questions received from 2017 to 2021. One of the interesting questions asks: Is it possible to have a Remote Location ("satellite site")?

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20.09.22

Labeling Requirements for IMPs Amended

The European Commission finally adopted the revised Annex VI to the CTR as regards labelling requirements for IMPs. The amendment eliminates the obligation to include an expiry date on the primary packaging of IMPs in specific circumstances.

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14.09.22

ANVISA´s Q&A on Medical Cannabis for Clinical Investigations

The Brazilian Health Regulatory Agency, ANVISA, published answers to questions received during a webinar on clinical research with medicinal Cannabis held in May this year. One of the important questions addressed is: How can batch reproducibility be demonstrated?

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13.09.22

FDA's recommended Font and Font Size for Instructions for Use Labeling

The FDA published now a guidance document on Instructions for Use (IFU) labeling. What is the recommended font and font size?

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13.09.22

UK changes SUSAR Reporting for IMPs

The eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September and only SUSARs via the ICSR Submissions portal will then be accepted.

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07.09.22

Ph. Eur. Survey for DEHP Plasticiser Alternatives

Due to a change in REACH, the Ph. Eur. is considering to replace the plasticiser DEHP and is therefore seeking information from manufacturers. The deadline for replies is 30 September 2022.

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16.08.22

CTIS & EudraVigilance - Update for Sponsors of Clinical Trials

The EMA provides guidance for sponsors who have to report SUSARs via EudraVigilance originated in the context of clinical trials. In addition the updated document "Key Information for Sponsors on CTIS" has been published.

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10.08.22

HMPC´s Update on Medical Cannabis

The EMA Committee on Herbal Medicinal Products (HMPC) published the minutes for the HMPC meeting held in May 2022. The Meeting Protocol contains several interesting developments regarding Cannabis. Will it be possible for regulatory submissions to use the well-established medicinal use pathway in the EU?

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27.07.22

Swissmedic´s New Website for Herbal Medicinal Products

The Swissmedic website for authorization of herbal medicinal products (HMPs) has been completely revised and updated. It provides information on simplified authorization procedures for HMPs, e.g. for "HMPs with known active substance".

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27.07.22

FDA issues revised draft Guidances for Track and Trace

The Drug Supply Chain Security Act (DSCSA) distribution security requirements will come into effect in November next year. To help trading partners comply with the DSCSA, the U.S. FDA recently issued revised versions of two previously published draft guidances.

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20.07.22

FDA Warning Letters for CBD Products used in Farm Animals

The FDA posted several Warning Letters to companies illegally selling cannabidiol products intended for use in food-producing animals due to safety concerns. The agency is taking these steps to protect animals and the safety of the food supply chain.

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