最新消息

PHILIPPINES: PILOT IMPLEMENTATION OF THE FDA CUSTOMER RELATION MANAGEMENT INFORMATION SYSTEM (CRMIS) — SEPTEMBER/OCTOBER 2023

PHILIPPINES: PILOT IMPLEMENTATION OF THE FDA CUSTOMER RELATION MANAGEMENT INFORMATION SYSTEM (CRMIS) — SEPTEMBER/OCTOBER 2023

  • 2023-09-27 05:49:24

The FDA has introduced the Customer Relation Management Information System (CRMIS), a digital platform that enables stakeholders and the public to submit inquiries and follow-ups. The system began on August 28, 2023, and will run until November 30, 2023, as part of the FDA's commitment to improving public health services and IT infrastructure.

了解更多
PHILIPPINES: PFDA Released FDA Circular No. 2021-002-C Further Extending the Application Period for CMDN for Class B, C, and D Medical Devices – April/May 2023

PHILIPPINES: PFDA Released FDA Circular No. 2021-002-C Further Extending the Application Period for CMDN for Class B, C, and D Medical Devices – April/May 2023

  • 2023-04-24 09:37:45

On March 31, 2023, PFDA has once again extended the application period for one more year for medical device products that were previously considered non-registrable, which currently fall under AMDD risk class B-D. PFDA cites the risk of disrupting the supply chain that may negatively impact the quality of the healthcare system in the country.

了解更多
PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

  • 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

了解更多