Brazil’s Health Authority requires Registration Holders to send daily information to ANVISA regarding drugs necessary in COVID-19 Pandemic
Companies that hold drug registrations must provide Anvisa daily information about the manufacture, import and distribution of anesthetics, sedatives, neuromuscular blockers and adjuvant agents, among other drugs used to maintain the lives of patients infected with the new coronavirus (Sars-CoV-2).
Colombia’s Invima modifies administration measures due to COVID-19 pandemic
Invima changes the transitional administrative measures under Resolution 2020012926 of 3rd April 2020 due to COVID-19
China’s NMPA releases new regulation on the Registration of Biologics in China
China’s NMPA releases on June 30,2020, No. 43 of 2020 to regulate biologics efficiently, NMPA has divided biologics into 3 categories.
Brazil’s CMED urges Covid-19 pharmaceutical companies to Apply Minimum Discount
In Brazil, drugs and pharmaceuticals must follow “the minimum discount rule” of the Drugs Market Regulation Chamber (CMED) for public procurement of drugs and pharmaceuticals inputs
US FDA releases COVID-19 vaccine guidance
The United States Food and Drug Administration (USFDA) recently released a guidance for COVID-19 vaccine demonstrating at least 50% effectiveness in a placebo-controlled trial.
EMA waives fees for orphan drug consultations
European Medicines agency (EMA) updates their executive decision for orphan drug development of waiving fees for academic organizations.
China’s NMPA Introduces New Revised Regulation for Drug Approval by Foreign Companies
Overview: China’s National Medical Product Agency (NMPA) proposes a revision on pharmaceutical approval. The revision focuses mainly on generic drugs and how to increase the safety requirements for clinical trials, limit false clinical data and encourage drug approval process. China additionally released the second batch of urgently needed drugs from foreign manufacturers. New Drug Review […]
The Newly Enacted CARES Act reforms the FDA OTC Monograph Process
The United States Food and Drug Administration reforms the Over the Counter (OTC) process under the CARES Act signed by Congress in March ’20 to provide emergency relief affected by the COVID-19 pandemic.
EMA waives GMP inspection fees during COVID-19
EMA announces GMP inspection fees will be waived fully for sites that undergo remote inspections during COVID-19 pandemic.
Registration of Biologics in Brazil
Trying to register your biologic in Brazil? Read GRP’s blog to get a greater understand of the regulations, pathways and timelines.
Brazil’s Anvisa announces new flow for requesting copies of api and drug information
On May 11, 2020 Brazil’s ANVISA announces that the General Management of Drugs and Biological Products (GGMED) of Anvisa has a new flow for requesting and supplying copies of the registration process of drugs and active pharmaceutical ingredients (APIs).
Registration of a New Molecule in Mexico
In Mexico, manufacturers who seek market authorization (Sanitary Registration) for their new drug must first request approval of their products as new molecules from the New Molecules Committee (NMC) of COFEPRIS