International Pharmaceutical Regulatory Monitor

The European Medicines Agency (EMA) will issue guidance this month on key information drugmakers must submit to support the safety monitoring of all medicines authorized and registered in the EU, whether at the centralized or national level. Includes the full text of EMA Pharmacovigilance Implementation Plan.

The European Medicines Agency (EMA) is revising its guideline on anticancer drug development, placing additional emphasis on the use of biomarkers.

The European Commission is giving Italy two months to begin processing marketing authorization applications for generic versions of currently patented drugs.

Drugmakers developing biosimilars of popular multiple sclerosis (MS) drugs containing interferon beta need only conduct in vivo studies in animals if in vitro bioassays raise concerns, updated European Medicines Agency (EMA) guidelines state.

Adverse event reports held in the EudraVigilance database are not automatically protected from public disclosure under EU law, the European ombudsman finds in a case involving the European Medicines Agency (EMA) and the antibacterial Septrin.

The European Medicines Agency (EMA) has updated its draft guidelines on drug master files with new language promoting sharing of drug data assessments among multiple EU authorities.

The European Commission is seeking stakeholder input on extending good manufacturing practice (GMP) requirements for finished drug products to active pharmaceutical ingredients (API).

The international Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) has revised its charter to include language promoting global harmonization of good distribution practices (GDP) and confidentiality in data sharing.

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has been acting as an observer in the U.S.–EU pilot program for parallel assessment of new drug applications with quality by design (QbD) components.

In an attempt to bolster China’s image as a clinical trial destination, the State Food and Drug Administration (SFDA) has issued two guidelines to streamline Phase I clinical studies.

A proposed Indian rule that would let ethics committees decide the cause of serious adverse events and the level of SAE compensation provided to trial participants could make conducting high quality, scientifically valid trials in the country impossible, the Association of Clinical Research Organizations (ACRO) says.

An updated Health Canada guidance provides advice on when to include women from drug and device trials, including women who are pregnant or breastfeeding.

Drug sponsors could experience greater certainty during drug reviews if the U.S. Food and Drug Administration’s (FDA) upcoming pilot program to standardize the evaluation of new products is a success.

The U.S. Food and Drug Administration (FDA) is finishing a final guidance on co-development of two or more novel drugs for use in combination and hopes to release it in the next few months, Center for Drug Evaluation and Research Director Janet Woodcock tells IPRM.

Drugmakers and industry trade groups are calling for speedy passage of the Prescription Drug User Fee Act (PDUFA) with few amendments outside the agreed-upon goals letter.

The U.S. Food and Drug Administration (FDA) should clarify how to handle individual case safety reports (ICSR) when an event occurs in one country but is reported in another country, Sanofi says in comments to a draft guidance on the reports.