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Trending topicsCHMP Meeting Highlights (23–26 March 2026)
European Medicines Agency (EMA) published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) held from 23 to 26 March 2026. The meeting…
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Regulatory Affairs
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ImportantSingapore Updates Therapeutic Product Registration with eCTD Adoption and CMC Declaration Requirement
The Health Sciences Authority (HSA) has introduced regulatory updates related to therapeutic product registration. These updates include the formal adoption of the electronic Common Technical Document (eCTD) format…
Effective Signal Management: Bridging Data Detection and Regulatory Action
In the evolving landscape of pharmacovigilance, signal management has become a central pillar in ensuring drug safety and maintaining compliance with global regulatory affairs requirements. It goes beyond…
ImportantEMA Introduces New PRIME Tools to Accelerate Medicine Development in the EU
The European Medicines Agency (EMA) has introduced three new features under its PRIME scheme to enhance the development of medicines targeting unmet medical needs. These tools aim to…
ImportantEgyptian Drug Authority Announces Public Consultation on Draft Guideline for Biological Products Registration
On 10 February 2026, the Egyptian Drug Authority (EDA) announced the launch of a public consultation on a new draft regulatory guideline titled: Guideline for Content File of…
ImportantNMPA Strengthens Drug Regulation Under Revised Drug Administration Rules
China’s (NMPA) has announced enhanced regulatory measures following the formal revision of the Implementing Regulations of the Drug Administration Law. The updated rules were promulgated through a State…
ImportantAdvancing Vaccine and Medicine Safety in LMICs
Active safety surveillance plays a vital role in ensuring the safety of vaccines and medicines after they are approved and introduced into clinical use. This is especially important…
Trending topicsAgentic AI Goes Live at FDA
The U.S. Food and Drug Administration (FDA) has announced the rollout of agentic artificial intelligence (AI) tools to all of its employees, marking a significant expansion of the…
WarningsUK Expert Group Recommends Stronger Warnings on Antidepressant Risks
An Expert Working Group (EWG) of the Commission on Human Medicines (CHM), advising the Medicines and Healthcare Products Regulatory Agency (MHRA), has completed an in‑depth review of how…
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