Mexico’s COFEPRIS promotes the production of generic drugs with new operating rules
COFEPRIS establishes operating rules to promote the production of generic drugs in Mexico, by eliminating criteria that limited their production and their availability at more accessible prices for the population.
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.
Social Media Advertising in Australia
Therapeutic Goods Administration (TGA) oversees advertisement of goods in Australia and has set forth the requirements of advertising
Brazil’s ANVISA issues new Resolution for the direct import of products by Healthcare Centers
On May 12, 2020 ANVISA published new resolution RDC Nº 383 that addresses the direct import of products by health centers.
United States’ FDA issues guidance on Pre-IND meetings during COVID-19
In an effort to support sponsors responding to the public health emergency of COVID-19 pandemic, On May 2020, the FDA provided a guidance to assist sponsors in preparing pre-IND meeting requests for COVID-19 related drugs (human drugs and biological products).
Singapore’s HSA implements Provisional Authorization Process to Expedite Approval of COVID-19 Diagnostic Tests
Singapore HSA implements provisional authorization process for kits intended to detect and/or diagnosis COVID-19 infection to address the need for COVID-19 diagnostic tests.
New Fees and Requirements for the Registration of DMFs of APIs in China
On March 2020, the Chinese health authority NMPA increased the registration fee of DMFs for APIs and added new registration requirements.
Global Regulatory Partners is Joining the Fight Against Coronavirus (COVID-19)
Global Regulatory Partners is Supporting the Fight Against Coronavirus (COVID-19) -Contact US to Learn More
The FDA publishes FY 2019 GDUFA Science and Research Report
The FDA’s FY 2019 GDUFA report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts.
Anvisa’s Call Notice 2/2020 : Similar Drug Notice
On Thursday (1/30), Anvisa published Call Notice 2/2020 , aimed at requesting information on similar drugs registered in Brazil.
Accelerated Approval of Detection Reagents of Coronavirus in China
The Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent has shown the NMPA accelerated approval of seven NAD Reagents in only four days before going to the market.
HOW TO FILE A DMF FOR AN API IN JAPAN
GRP- blog explains the PMDA’s DFM application process and lists the necessary content needed for API submission to the PMDA.