Regulatory Affairs Professionals Society

The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the healthcare products sector.

[Regulatory Affairs Professionals Society @RAPSorg]

FDA recently finalized two guidances on studies to assist sponsors in establishing bioequivalence for new and generic drugs. One focuses on BE studies with pharmacokinetic endpoints, and the other on statistical methods for analyzing these studies.

https://t.co/3J3dCPaONq

[Regulatory Affairs Professionals Society @RAPSorg]

A recent survey published by Team-NB reveals that the growth of certificates for the Medical Device Regulation and In Vitro Diagnostic Regulation slowed in 2025 compared to previous years. https://t.co/MUGIW9mOnW

[Regulatory Affairs Professionals Society @RAPSorg]

The European Commission has published an analysis detailing the benefits of enacting the European Biotech Act, which was proposed last year as a means of increasing the EU’s competitiveness in the sector, in part by simplifying regulations. https://t.co/E8j6JQHd1h

[Regulatory Affairs Professionals Society @RAPSorg]

Congratulations to our newest RCC holders, who now have a credential that validates their knowledge of European regulations in medical devices or IVDs.

Learn more about the RCC here: https://t.co/mzUVRyNsBY

[Regulatory Affairs Professionals Society @RAPSorg]

The European Commission has adopted a roadmap to phase out the use of animals in chemical safety assessments, including for pharmaceuticals.

https://t.co/AIPSN64gdv

[Regulatory Affairs Professionals Society @RAPSorg]

In the Journal of Regulatory Affairs, Natalia Tsygankova provides a practical guide to the key EAEU regulatory institutions, the hierarchy of normative documents, registration procedures, and eCTD dossier requirements for EAEU regulatory success: https://t.co/JwIjtK0tIx

[Regulatory Affairs Professionals Society @RAPSorg]

As Europe’s regulatory community united in Lisbon at #RAPSEuroConvergence, Ferdous Al-Faruque was on the scene for Regulatory Focus.

Read his reporting here: https://t.co/TOGyGLxSFA

[Regulatory Affairs Professionals Society @RAPSorg]

FDA recently issued warning letters to drugmakers in Japan and the US, as well as a producer of active pharmaceutical ingredients based in India, citing the firms for violations of current good manufacturing practice. https://t.co/7v4rcpUh87

[Regulatory Affairs Professionals Society @RAPSorg]

Pharmaceutical industry groups say they support FDA draft guidance on new approach methodologies (NAM), which aims to replace animal testing with innovative models, such as in silico modeling, to assess drug safety. https://t.co/hpSimGtBm9

[Regulatory Affairs Professionals Society @RAPSorg]

The European Medicines Agency, in partnership with the European Commission, and the Heads of Medicines Agencies, has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area. https://t.co/mC0rzPf6bC

[Regulatory Affairs Professionals Society @RAPSorg]

An agency official presented three case studies demonstrating how sponsors effectively utilized real-world evidence and real-world data to secure approval for their products at FDA's Regulatory Education for Industry (REdI) meeting this week: https://t.co/CHpNnYgAYS

[Regulatory Affairs Professionals Society @RAPSorg]

FDA has issued warning letters to two researchers for failing to meet good clinical practice requirements and for not complying with their own trial protocols. https://t.co/G7LNzEAQSY

[Regulatory Affairs Professionals Society @RAPSorg]

#RAPS50For50 celebrates Kate Stockman, who just finished playing a crucial role at #RAPSEuroConvergence 2026!

Learn more about Kate and see how you can nominate someone here: https://t.co/qu5pzIvgze

[Regulatory Affairs Professionals Society @RAPSorg]

PhRMA said FDA's recent draft guidance on marketing exclusivity for new clinical investigations provides essential clarity on the types of applications that are eligible for the incentive. However, both PhRMA and Novartis said clarification is necessary.
https://t.co/hjsVAreX67

[Regulatory Affairs Professionals Society @RAPSorg]

A panel of experts at #RAPSEuroConvergence discussed how AI is being applied throughout the product lifecycle, from compiling premarket application submissions to assisting in the conduct of conformity assessments. https://t.co/IpbWdyREvU

[Regulatory Affairs Professionals Society @RAPSorg]

FDA is asking for input on repurposing older drugs for new therapeutic uses to address unmet medical needs across a wide range of therapeutic areas. https://t.co/7xHITwhQyx

[Regulatory Affairs Professionals Society @RAPSorg]

A panel of European regulators answered questions during a town panel discussion at #RAPSEuroConvergence on the implementation of the new EU Pharmaceutical Legislation and the use of AI in regulatory and drug development.

Read their takeaways: https://t.co/8mFGNfgTDF

[Regulatory Affairs Professionals Society @RAPSorg]

The top observations identified in Form 483 reports from inspections conducted under the recently implemented QMSR include risk management, outsourcing and purchasing, and complaint handling and feedback, an FDA's official says.
https://t.co/2NIPtar6wU

[Regulatory Affairs Professionals Society @RAPSorg]

FDA has released a final guidance document with immediate effect advising sponsors on chemistry, manufacturing, and controls flexibilities for cell and gene therapy products developed for biologics license applications. https://t.co/1icTQcNcYZ

[Regulatory Affairs Professionals Society @RAPSorg]

Come read a RAPS member-exclusive chapter of our new book and share your takeaways with other RAPS members!

Regulatory Reading Club is back: https://t.co/M1DouZ0ki5