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 […]
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.
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.
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.
Mexico’s Cofepris releases provision for ventilator requirements during COVID-19 Pandemic.
On April 6, 2020 Mexico’s Cofepris released provisions on the minimum requirements for ventilators to receive approval during the COVID-19 pandemic.
Singapore announces facilitated Importation of Hand Sanitizers, Masks, Thermometers and Protective Gear
Since January 31, 2020, importers of the certain medical devices do not require an importer’s license from Singapore’s Health Science Authority (HSA).
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.
BRAZIL APPROVES IMPORTATION OF MEDICAL CANNABIS
ANVISA new regulatory framework creates a new class of products subject to health surveillance: Cannabis- based products.
ONE-TIME IMPORT OF BIOLOGICAL PRODUCTS FOR CLINICAL TRIALS IN CHINA
CDE releases No. 94 of 2018 stating that certain biological products maybe imported for a one- time for clinical trial purposes.