FDA-Advancing Real World Evidence Program
On 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.
FDA Approves Free Sale of OTC Hearing Aids
In August 2022, the FDA finalizes the historic rule allowing millions of Americans access to over-the-counter hearing aids.
Monkeypox: Anvisa guides health services on case management
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.
Monkeypox Reaches Brazil: Anvisa suggests mask and isolation to postpone arrival of smallpox
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.
CHINA’S HAINAN BOAO PILOT ZONE OPENS SPECIAL ACCESS FOR NEUROLOGICAL INNOVATIVE PRODUCTS
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
US-FDA Over-The-Counter Monograph Drug User Fee Program (OMUFA)
On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022
REGISTRATION OF DRUG MASTER FILE (DMF) IN JAPAN
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.
US-FDA Formal Meetings with OTC Sponsors
Overview: On February 1st, 2022, the US Food and Drug Administration (FDA) issued a draft of guidance on formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency.The guidance clarifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, content of meeting requests […]
Brazil’s Anvisa approves Anvisa regulates the use of self-tests for Covid-19
Brazil’s Anvisa approves resolution establishing requirements for registration, distribution, commercialization, and use of covid-19 self-tests.
Brazil’s Anvisa approves Rules for travelers entering Brazil
Foreign and Brazilian travelers abroad must present the Negative PCR exam to the airline company responsible for the flight, before boarding
Brazil’s Anvisa approves extending the use of CoronaVac to children and adolescents aged 6 to 17 years
The emergency use authorization granted this Thursday (01/20) is valid only for the age group 6 to 17 years old.