The Pharmaceuticals and Medical Devices Agency (PMDA) has published advice on ensuring the safety of healthy adult participants in Japanese bioequivalence studies.
Australia’s Therapeutic Goods Administration (TGA) has adopted two new medicine labeling standards, starting a five-year countdown to mandatory compliance with the updated requirements.
The Indian government has approved a program for monitoring adverse events associated with medicines and biological products used in organ and tissue transplantation.
Singapore’s Parliament has advanced legislation to build “a more coherent, future-ready system” that provides clarity and predictability for the healthcare industry.
Australia’s Therapeutic Goods Administration (TGA) has started a consultation into proposed changes to support automated decision making (ADM) for listed medicine variation applications.
The Saudi Food and Drug Authority (SFDA) has launched the New Accelerator Program for Drugs in Rare Diseases (NADR) to streamline the development, evaluation, and authorization of drugs for rare diseases.
The Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory authorities.
