The European Medicines Agency (EMA) on Thursday opened for consultation a new guideline on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products (ATIMPs). The 53-page guideline addresses development, manufacturing and quality control, featuring sections on quality documentation (including parts on the active substance and the investigational medicinal product)...

The European Commission on Tuesday launched a targeted consultation to provide input on a revision of its guideline on the content and format of applications for orphan drug designation, as well as the transfer of designations between sponsors.   "The comments received will be taken into account by the European Commission in the finalization of the guideline on the format and content of application for designation as orphan medicinal products and on the transfer of des...

The European Medicines Agency (EMA) on Monday released a draft version of its guideline on developing antibacterial medicines for consultation.   The 30-page guideline, which is now on its third revision, has been updated to reflect a harmonized approach to antibacterial drug development based on the tripartite discussions between EMA, the US Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency.   "Antimicrobial resistance is a glob...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   CDSCO Seeks Feedback on Planned Risk-Based Pharmacovigilance Inspection Program   The Central Drugs Standard Control Organization (CDSCO) is seeking feedback a proposed risk-based pharmacovigilance inspection model. CDSCO plans to adopt a four-year cycle for pharmacovigilance inspections and prioritize the assessment of companies that introduce new drugs to the marke...

The European Medicines Agency (EMA) on Wednesday announced the adoption of a guideline, first drafted in 2011, on the clinical evaluation of medicinal products in the treatment of the autoimmune disease rheumatoid arthritis (RA). "Currently, several biomarkers which may predict disease progression and response are under development. In the future, this may lead to a more individually targeted treatment approach," the guideline said. "Despite significant advances in...

The US Food and Drug Administration (FDA) on Thursday released a draft guidance for consultation on a revision to the International Council for Harmonization (ICH) guideline on reproductive toxicity testing. The draft ICH guideline, S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals , was endorsed by the ICH Assembly in August and is currently in Step 3 of the formal ICH procedure as participating regulators hold public consultations on the guideline...

The European Medicines Agency (EMA) on Tuesday released for consultation a new guideline to help companies develop new medicines, direct-acting antiviral agents, monoclonal antibodies and vaccines to treat and prevent infections caused by the respiratory syncytial virus (RSV). According to EMA, RSV is a common respiratory virus that usually causes mild, cold-like symptoms that most recover from, though RSV can be serious, especially in infants and older adults. Curr...

The European Medicines Agency (EMA) on Monday issued two draft revised guidelines on plasma-derived and recombinant coagulation factor VIII products that remove requirements for conducting clinical studies in previously untreated patients (PUPs). Background Factor VIII products are used to treat or prevent bleeding in patients with hemophilia A (congenital factor VIII deficiency). The development of inhibitor antibodies is one of the greatest potential complications inv...

The European Medicines Agency (EMA) on Tuesday opened for public consultation a draft guideline on serious breaches of clinical trial regulations or clinical trial protocols. The agency says the guideline is intended to "outline the practical arrangements for notification of serious breaches … provide advice on what should and what should not be classified as a serious breach and what must be reported … [and] To outline possible actions that may be taken by the EU/...

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the sponsor and member state inspections. "This guideline aims to collate and explain the requirements for the TMF as covered in the Regulation [(EU) No 536/2014] and ICH-GCP E6 to assist organisations in ma...

As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday published a new final guideline on a harmonized terminology for reporting such events. "Widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection by adverse event management systems enabling a faster response ...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The text deals with how to mitigate the risk of false positives arising when clinical trials look at multiple treatment groups and endpoints. EMA’s guideline is applicable to most clini...