On January 2023, The U.S. Food and Drug Administration (FDA) has issued a proposed rule to amend color additive regulations to increase fees for certification services. ves
On October 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) has published new quality standards and specifications of 2,647 ingredients and additives that can used in Quasi-drugs.
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
The FDA publishes updated Definitions of Face‑to‑Face Formal Meetings.
In October 2022, the U.S. Food and Drug Administration is announcing the Advancing Real-World Evidence (RWE) Program
China’s NMPA Announces they will Start Electronic system for Drug related Registration Certificates (2022)
China’s NMPA Announces they will start on Issuance of Drug Electronic Registration Certificates starting November 1st, 2022. China’s National Medical Products Administration (NMPA) will issue drug registration certificates in electronic version, which is as legally valid as the paper version.
In August 2022, the FDA finalizes the historic rule allowing millions of Americans access to over-the-counter hearing aids.
The National Health Surveillance Agency (Anvisa) provides guidance on prevention and mitigation measures for Monkeypox in hospitals, clinics and other health services that provide care to suspected and confirmed cases of the disease.
The National Health Surveillance Agency (Anvisa) is asking for reinforcement of non-pharmacological measures, such as distancing, use of masks and frequent hand hygiene, in airports and aircrafts, to delay the entry of the monkey pox virus into Brazil.
GRP’s Special program for Accelerated Market Access to China is offered to Foreign Pharmaceutical, Biotech and MedTech companies that have innovative products that are already approved in USA and/or EU or Japan
On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022
In Japan, the Drug Master File (DMF) is called “Master File” or “MF”. The Purpose of DMF is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products. The foreign manufacturers of APIs can apply for DMF registration.