Brazil’s Anvisa produces new committee for the accelerated submission of COVID-19 related clinical trials.
Anvisa has established a Committee for Evaluation of Clinical Studies, Registration and Post-registration of Drugs for prevention or treatment of Covid-19.
Brazil’s Anvisa publishes Service Orientation (OS) that may provide simplification of clinical trial applications (DDCM)
Anvisa pusblishes Service Orientation (OS) 88/2020 provides details on procedures for reviewing documents required for submission of the Clinical Drug Development Dossier (DDCM) and changes that potentially impact the quality or safety of experimental drugs, active BE drugs or placebos.
FDA holds up UDI enforcement for Class I device
The FDA delays the enforcement of Unique Device Identification (UDI) for Class I medical devices and will come in action from 24 September 2022.
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
FDA resumes on-site domestic inspection
The United States Food and Drug Administration lifts halt on domestic routine surveillance facility inspections from week of July 20, 2020.
US FDA releases its first patient focused drug development (PFDD) guidance
The US FDA has released its first patient focused drug development (PFDD) guidance. This guidance is the first methodological guidance( referred as guidance 1) and that will be followed by 3 more guidance’s on this topic.
How Cosmetic companies can stay complaint online during the COVID-19 Pandemic
The pandemic has produced new obstacles for all businesses including the cosmetic industry. the pandemic has produced a shift from shopping in stores to shopping online. the online platform is new media to many businesses and with it brings its own obstacles such as regulation requirements that differ by country.
US FDA Facilitates Intellectual Property Rights For Dietary Supplements
The US FDA proposes useful tools to register innovative dietary supplement for New Dietary Ingredient – Master file (NDI-MF).
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.