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Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Stakeholders are being encouraged to weigh in on the European Chemicals Agency (ECHA) 60-day public consultation period related to a planned ban on per-and-polyfluoroalkyl (PFAS) substances, also known as forever chemicals.

Following the trend of other regulators, the European Medicines Agency (EMA) is taking steps to reduce the need for animal testing. The agency has issued a draft qualification opinion for a new approach methodology (NAM) using virtual control groups (VCG) in dose range finding studies that reduce the need for concurrent control groups that use animals.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The European Medicines Agency (EMA) has finalized a document with recommendations on using the European Medicines Regulatory Network (EMRN) Data Quality Framework (DQF) when submitting premarket applications that include real-world data.

Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good manufacturing practices.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The European Medicines Agency (EMA) has finalized updated guidance on the information required for the manufacture and control of active substances used in medicinal products, with a 1 September date of application.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance on how marketing applicants can use non-animal data in their applications. The move comes on the heels of a similar initiative by the US Food and Drug Administration (FDA) to reduce the need for animal testing in drug development.

The European Medicines Agency (EMA) has provided guidance to help manufacturers adhere to good manufacturing practices (GMPs) when using three-dimensional (3D) printing technology, also known as additive manufacturing, in the production of solid oral dosage forms.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Top European officials said they are optimistic that amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will be enacted quickly, but the amendments must also comply with legislative requirements, which will take several months.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The European Medicines Agency (EMA) has introduced three features to improve its PRIME scheme for supporting the development of medicines targeting unmet medical needs.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The European Medicines Agency (EMA) has released a concept paper proposing a future reflection paper on the development of non-clinical proof-of-concept (POC) studies to support novel oncology treatments for the pediatric population.

The European Medicines Agency (EMA) has published a strategy for implementing international guidelines on managing post-approval safety data.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.