China’s CMDE Announces new REGULATIONS ON THE SUPERVISION AND ADMINISTRATION OF CUSTOMIZED MEDICAL DEVICES for Clinical TRIALs.
China’s CMDE Announces new REGULATIONS ON THE SUPERVISION AND ADMINISTRATION OF CUSTOMIZED MEDICAL DEVICES for Clinical TRIALs.
Drug Master File (DMF) in China
Since January 1, 2018, CFDA has not been accepting Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials registration application independently. The Active Pharmaceutical
China Expediting the Review and Approval of Drugs to Treat Life Threatening Diseases
Chinese health authority published a list with 48 orphan drugs that qualify for an expedite review process of their registration application. The 48 drugs are used for the treatment or prevention of rare and life-threatening diseases, and have alread…
FDA Waiving the Informed Consent for Minimal Risk Clinical Studies
To date, FDA requires all subjects to provide their informed consent before participating in any clinical trial, except when there are life-threatening situations or emergency research conditions.
On November 2018, FDA proposed a new rule that wil…
FDA New Pilot Program for Medical Device Conformity Assessment Accreditation
By September 20120, the US Food and Drug Administration (FDA) is planning to lanch its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment (ASCA).
ASCA Pilot Program goa…
New Program for the Review of Innovative Medical Devices in China
The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program that will take effect December 1, 2018.
