Regulatory Intelligence, straight to your mailbox

FDA: Device or Drug?

The FDA has issued an “Immediately in Effect Guidance” after a Court ruled that the FDA can no longer regulate as drugs the ophthalmic dispensers packaged together with ophthalmic drugs.

EMA Draft Guidance on PPP

The EMA has published a new draft GVP Module XVI Addendum III, which covers Pregnancy Prevention Programmes (PPP) and other Pregnancy-specific Risk Minimisation Measures.

France: Safety Reporting & EU CTR

The ANSM has published Module V and VI of the Notice to Sponsors, which clarify the safety reporting requirements for clinical trials under the new EU Clinical Trials Regulation (EU CTR).

Pakistan GVP Guidelines

The Drug Regulatory Authority of Pakistan (DRAP) has published the first edition of the guidelines on Good Pharmacovigilance Practices for Product Registration Holders.

Malaysia GVP Inspections

The Malaysian authorities have issued guidance to support a new programme of voluntary Good Pharmacovigilance Practices (GVP) Inspections.

EU Standard for ePI

European Authorities have adopted a Common Standard for electronic Product Information (ePI), which will support the provision of harmonised and up-to-date information on medicines.

DARWIN EU

The EMA has initiated the establishment of DARWIN EU, which is intended to provide EU Authorities with valid and trustworthy real-world evidence through a network of real-world data sources.

RMP & COVID-19 Vaccines

The EMA has revised its guidance on Risk Management Plans (RMPs) for COVID-19 vaccines. The updates concern the requirements for summary safety reports, including their content and frequency.

CIOMS & Patient Involvement

CIOMS launched a public consultation on a new draft report, which provides “best practices” for the involvement of patients in various aspects of medicine development, regulation, and safety.

CTIS goes live

The new EU Clinical Trial Regulation (EU No 536/2014) became applicable as the EMA launched its Clinical Trials Information System (CTIS) on 31-Jan-2022.

EU CTR Q&As

The European Commission has published a revised version of the Q&A Document supporting the implementation of the Clinical Trials Regulation (EU) No 536/2014, which is now applicable.

ISO & ICSRs

It will become mandatory to report ICSRs to EudraVigilance in compliance with international ISO standards from 30-Jun-2022. The EMA has published information to prepare for the changes.

Clinical Trials in the UK

The MHRA has launched a consultation on proposals to improve and strengthen the UK clinical trials legislation, streamline clinical trial approvals and enable innovation.

MHRA GPvP Metrics

Safety Observer has produced a new article on its website, which provides the key learning points from the latest MHRA Pharmacovigilance inspection metrics report.