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Blog - MHRA Inspectorate


The pharmacovigilance systems of marketing authorisation holders are often dependent on multiple third parties; extensive outsourcing and partnering is a feature of the pharmaceutical industry as much as any other. This blog expands upon the areas identified as problematic for MAHs and service providers and provides points to consider when producing contracts and agreements text.

FDA issues REMS Draft Guidance

The FDA has issued 2 new draft guidance documents for consultation. The first document describes the development of a shared Risk Evaluation and Mitigation Strategy (REMS), whereas the other describes how the FDA will consider granting a waiver of this requirement. Both documents bring provisions intended to make the process more efficient and to discourage companies from using REMS to block generic competition.

Pharmacovigilance and Inspections

The MHRA has published a new GCP Inspections metrics report, which provides the details about the Critical Findings raised over the period covered. This includes a few Findings related to Clinical Drug Safety and the use of Reference Safety Information in the context of SUSAR and DSUR reporting. This particular topic will be one the themes for the next GCP Symposium, which will take place on 05 and 06-Sep-2018.

Product Safety News

Further to new study results becoming available, the EMA and FDA have issued Safety Alerts regarding two issues. This concerns the HIV medicine dolutegravir, which has been associated to a Potential Risk of Neural Tube Birth Defects. A decreased survival has also been observed with Keytruda and Tecentriq when used in monotherapy for the treatment of metastatic urothelial cancer in some patients.

Hot topics are taken from Safety Observer Lite 146, June 2018