Advisor 462

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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and possible limitations in trial site and hospital resources. • Remote source data verification (SDV): the verification of raw data in hospitals can be extremely difficult during the pandemic due to safety measures such as social distancing. Remote SDV to conclude a trial could facilitate the marketing authorisation of coronavirus treatments and life-saving medicines. • Communication to authorities: urgent actions to protect trial participants against any immediate hazard or other changes with an effect on patient safety or data robustness might become necessary to mitigate disruptions during the ongoing public health crisis. The guidance clarifies the classification and notification of these actions.

All these measures apply exclusively during the coronavirus pandemic, and will be revoked once the current health crisis in the EU/European Economic Area is over. Member States are encouraged to implement the harmonised guidance to the maximum possible extent to mitigate and slow down the disruption of clinical research in Europe during the public health crisis. At the same time, sponsors and investigators need to take into account that national legislation and derogations cannot be superseded. Member States should provide additional clarity on specific national legal requirements and derogations, as appropriate.

Source:

New European PV inspection follow-up procedures The European Medicines Agency (EMA) has issued a new guideline that explains follow-up procedures for pharmacovigilance (PV) inspections in the EU.

The 15-page guideline came into effect on 1 May 2020 and supersedes a previous document from 2014 (EMA/INS/PhV/192231/2014). It includes several new sections and provides a more detailed timeframe for post- pharmacovigilance inspection activities. After every inspection, the competent authority is required to report on whether the marketing authorisation holder (MAH) complies with the requirements laid down in Directive 2001/83/EC. According to Article 111(8) of the Directive, if the pharmacovigilance inspection finds that the MAH does not comply with the pharmacovigilance system as described in the Pharmacovigilance System Master File and with Title IX of the Directive, the competent authority of the Member State concerned has to inform the MAH of the deficiencies and give them an opportunity to submit comments. Other Member States, the EMA and the European Commission also have to be informed.

Any identified non-compliance has to be rectified by the MAH in a timely manner through the implementation of a corrective and preventive action (CAPA) plan. Inevitably, depending on the nature of the findings, some pharmacovigilance inspections will require significant follow-up and management. The new guideline defines the steps in the follow-up of pharmacovigilance inspections and the responsibilities of the various parties involved, including the following: • the process for requesting a CAPA plan from the MAH – when an inspection report has been issued to the MAH (or other inspected organisation), the lead inspector should propose date(s) for the receipt of responses to the findings listed in the inspection report; this is generally within 30 working days following receipt of the report, unless there are specific national requirements for provision of responses or the lead inspector determines that an expedited response should

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Issue 462, 2020

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