In an effort to boost the safety of approved drugs, the European Medicines Agency (EMA) is piloting a new procedure that would allow companies to seek the agency's advice on designing post-authorization safety studies (PASS).

Background

Currently, EMA and its Scientific Advice Working Party (SAWP) offer scientific advice to companies developing medicines.

The advice is primarily intended to help drugmakers design "trials that are scientifically sound and generate robust data." When giving scientific advice, EMA will answer questions given by a drugmaker "in light of the current scientific knowledge, based on documentation provided by the company."

EMA notes that its advice is "prospective in nature" and is meant to advise companies on strategic issues during development, and is not meant to pre-evaluate clinical data.

Post-Authorization Safety Studies (PASS)

Once a drug is authorized, companies are required to conduct various types of postmarket surveillance to ensure their product's safety once on the market.

One way this is done is by conducting PASS. These studies are either non-imposed, meaning a company undertakes the study of its own volition, or imposed. An imposed PASS is usually carried out when a product is authorized to meet an urgent need before more thorough clinical studies can be completed, or by request of the Pharmacovigilance Risk Assessment Committee (PRAC).

PASS Pilot

Beginning July 2015, EMA is expanding its scientific advice procedure to include scientific advice for designing PASS.

Both SAWP and PRAC will be involved in the pilot, and all advice will be endorsed by PRAC before being issued.

EMA says the pilot will primarily focus on non-imposed PASS, and expects the advice will help companies design higher quality safety studies that will "provide useful information on a medicine in a real-life setting."

EMA says companies participating in the pilot can benefit from:

• "a strengthened PRAC-SAWP interaction
• a lifecycle approach to medicines advice with integrated advice on all aspects of medicines development from involved Committees
• support for proactive pharmacovigilance planning
• advice at an early or late stage of the protocol development
• targeted advice on key issues
• a well-defined procedural timetable
• a pre-submission interaction with Agency secretariat to consider suitability and validity of the dossier
• a face to face meeting with involved regulators during the procedure
• engagement with patient representatives
• options to include other stakeholders such as HTAs or FDA further supporting optimised evidence generation
• the possibility of seeking follow-up advice"

The pilot is entirely voluntary and will run for one year. EMA has also updated its questions and answers guide for scientific advice to reflect the pilot and has published a letter of intent for companies wishing to participate in the pilot to complete.

EMA, PASS Q&A (Question 10)