FDA RELEASED THE FINAL VERSION OF 6 GUIDANCE’S FOR GENE THERAPY
On 28 January 2020, US FDA released six (6) final guidance documents on Gene Therapy (GT) products.
NMPA PUBLISHES NEW GUIDELINE ON HOW TO ADDRESS LETTER OF DEFICIENCIES FOR MEDICAL DEVICE COMPANIES IN CHINA
On January 16, 2020 the NMPA publishes guideline explaining how medical device manufacturers should respond to a letter of deficiency from NPMA.
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.
Changing of API registration in China NMPA- What you need to know
On January 17, 2020 The Center of Drug Evaluation has published a Notice on improving the relevant functions of the API registration system,
Indonesia: A look at Indonesia’s Halal Product Law
Indonesia’s Halal Product Law Criteria and a review of the halal global market and foreign company halal accreditation process
ISO revises guidelines to address the risk management of medical devices
Overview: On December 18 of 2019, The International Organization for Standardization (ISO) presented their new and improved guidelines on medical devices ISO 14971, . The document instructs on the process of risk management for medical devices such as, software as medical devices, in-vitro diagnostic devices and other products which might defer medical devices classification under some […]
Fecal Microbiota Transplant Products guidelines published by TGA
TGA released new guidelines on fecal microbiota transplant (FMT) products which states how FMT products would be classified and regulated.
Regulation of vaping products in Canada
The Canadian government has established a regulatory framework for vaping products. As the incidence of vaping increases among the population, the government continues an aggressive campaign to lower and prevent interest of youths and adults who do not smoke tobacco.
US FDA Expands the Abbreviated 510 (k) Program to Well-known Medical Devices by — Implementing a Safety and Performance Based Pathway
The FDA expands the concept of the Abbreviated 510(k) pathway for certain well understood device types, using the Safety and Performance Based pathway.
Drug Master File (DMF) in China
The new system set up by the NMPA allows manufacturers to file the DMF directly, thereby reducing the approval time and respective cost involved.
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
On November 2018, FDA proposed a new rule that will allow investigators to request a waiver of the informed consent from the IRB for minimal risk clinical studies.