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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently announced a new agreement with the African Union Development Agency – New Partnership for Africa's Development (AUDA-NEPAD) to share information on good manufacturing practices (GMP) for pharmaceuticals and active pharmaceutical ingredients (APIs). The agreement aims to enhance capacity building for GMPs among African national regulatory authorities (NRAs).

The European Medicines Agency (EMA) is co-funding a one-year pilot program with the Bill & Melinda Gates Foundation to support the establishment of continental medicines review procedures in the African Union (AU). The program builds on work done over the past decade toward establishing an African Medicines Agency (AMA).

The US Food and Drug Administration (FDA) has withdrawn its membership in the Global Harmonization Working Party (GHWP) that largely represents Asian regulators. The agency said it decided to leave the organization after being sidelined on key issues.

Cincinnati, OH – Collective intelligence is necessary for the creation of standards for artificial intelligence. That was the message Pat Baird, senior regulatory specialist at Philips brought to the AI Summit held by the AFDO/RAPS Healthcare Products Collaborative.

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

Interpol has arrested 72 people for selling millions of dollars' worth of counterfeit drugs in a global dragnet across 89 countries during Operation Pangea. The international law enforcement agency said they seized $7 million worth of drugs, more than closed 1,300 websites, and initiated 325 new investigations between 3-10 October.

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

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

MONTREAL – The regulatory professional of the future will need to embrace change and deeper collaboration at a faster pace and on a greater scale than previously seen, according to panelists at the opening plenary session of RAPS Convergence 2023.

The last few years have seen unprecedented change in regulatory affairs through the impacts of the COVID-19 pandemic, a transforming regulatory environment, anticipated and unanticipated delays, and other changes. This year's RAPS Convergence will focus on taking what regulators have learned from these changes to prepare for the future of the profession.

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

Philippine FDA has proposed major changes to the section on specific guidelines, starting with new text on the conditions that different types of licensed organizations such as drug and medical device establishments must comply with. The new text clarifies that organizations that 3D print medical devices must apply for an LTO.

The International Medical Device Regulators Forum (IMDRF) released four final guidances this week that address cybersecurity best practices, verification and validation for personalized medical devices and post-market surveillance communication between regulators.

A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro diagnostics reform and discussed other legislative priorities for the agency, such as getting more data about the supply chain to prevent future shortages.

Regulatory professionals need a new guide to medical device regulations. We just wrote one.