Quality/GMPs

Articles

The construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

Gritgen Therapeutics Launches Commercial GMP Facility in China

The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.

FDA to Support Potential Use of Real-World Data to Generate Real-World Evidence for Regulatory Decision-Making

Adam C. Fisher, Phd, is Director of Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

The Manufacturing Edge on Path to Market

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Regulatory and Standard Setting Organizations Directory

Resources, Guidelines, and Guidance Documents Directory 

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Resources, Guidelines, and Guidance Documents

Regulatory and Standard Setting Organizations

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

Regulatory/GMP Compliance, Emerging Markets