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 […]
Brazil’s Anvisa outlines Pharmaceutical Registration Exceptions due to COVID-19
Anvisa has published a Resolution RDC Nº 392 2020, that defines the criteria for the application of exceptions to Good Manufacturing Practices and Import requirements for drugs and pharmaceutical during COVID-19.
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.
Singapore’s HSA Announces Guidance on 3-D Printing on Essential Medical Device for COVID-19
The Health Science Authority (HSA) released a guidance in response to the COVID-19 demand for medical devices like nasopharyngeal swabs, personal protective equipment, face shields and respiratory accessories.
China’s NMPA issues Guideline for changes of Raw Material in Passive Medical Device Products.( No. 33 2020)
China’s NMPA issued a guidance (No 33. 2020) on May 19, 2020 to provide a guideline and systematic approach for risk analysis of raw material changes in passive medical device products .
Brazil’s Anvisa Registration Requirements for COVID-19 Rapid Test
On May 14, 2020 Brazil’s Anvisa published information on the requirements of the registration of the rapid tests for COVID-19 in Brazil.
Opening Up America Again: The Phased Approach & OSHA recommendations on Work Safety
The United States White House and Center of Disease Control (CDC) have released on May 14 the phased approach on “Opening Up America Again.”
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.
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.