Tag 'Regulatory Affairs'

Emirates Drug Establishment announced the development of the country’s first fully AI-discovered and developed drug candidate by a research team at Insilico Medicine. This milestone…

Taiwan Food and Drug Administration announced the publication of the “Guidelines for Clinical Trial Applications of Human Extracellular Preparations.” The announcement was issued on April…

National Pharmaceutical Regulatory Agency (NPRA) announced the official launch of the GCP, GLP, BE and EC Inspection Dashboard on its website.   Purpose of the…

In the evolving landscape of pharmacovigilance, signal management has become a central pillar in ensuring drug safety and maintaining compliance with global regulatory affairs…

National Pharmaceutical Regulatory Agency announced an update to the application form used for the Certificate of Indication and Declaration Certificate for products registered with the…

State Medicines Control Agency (SMCA) published a notice regarding medicinal products that may be subject to the “sunset clause.” The agency compiled a list of…

U.S. Food and Drug Administration (FDA) issued a draft guidance for sponsors seeking approval of human gene therapy products that involve genome editing technologies. Once…

Federal Institute for Drugs and Medical Devices presents updates on the development of the Iris system in relation to the implementation of ICD-11 (International Classification…

Drug Control Authority (DCA) approved updated policies concerning products containing animal-derived materials through Circular NPRA.600-1/9/12 (31). This update introduces a risk-based approach for scientific justification…

European Medicines Agency (EMA) published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) held from 23 to 26…

The Health Sciences Authority (HSA) has introduced regulatory updates related to therapeutic product registration. These updates include the formal adoption of the electronic Common…

The European Medicines Agency (EMA) has introduced three new features under its PRIME scheme to enhance the development of medicines targeting unmet medical needs.…

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…

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…

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…