This ASEAN Variation Guideline concerns the variation applications submitted by the marketing authorization holder for pharmaceutical products for human use only and not including biologics.

During the product assessment, the ASEAN NRAs take into account and give significant weight to the assessment performed by the reference NRA or WHO to reach their joint regulatory decision.

This document aims to provide guidance on the preparation of a product registration application for general medical devices using the ASEAN Common Submission Dossier Template (CSDT).

What Are Clinical Trials? What are Branded (Patented)/ Generic Drug Products?

How can we submit an application for registration of a pharmaceutical/ drug product? Note: Only establishments with a valid License to Operate (LTO) from the FDA Philippines may apply for registration of a pharmaceutical/ drug product.

Jul 23, 2012 · ASEAN Common Technical Requirements (ACTR) National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

Aug 16, 2024 · The National Medicines Regulatory Authorities (NRA) of ASEAN Member States have developed a new procedure for marketing authorizations: the ASEAN Joint Assessment Procedure. This is a formal procedure in which the same marketing authorization application is simultaneously submitted to all participating NRAs.

According to ASEAN Sectoral Mutual Recognition Arrangement for GMP Inspection of Manufacturers of Medicinal Products, the JSC on GMP MRA recognizes and benchmarks with PIC/S Guide to GMP for Medicinal Products. 15 What is the timeline for JA Procedure? A full JA procedure should be completed within 150 days from the availability of the

Details on primary, secondary and higher-order structure and information on biological activity, purity and immunochemical properties ( when relevant ). Summary of impurities monitored or tested for during and after manufacture of drug substance. Compendial requirements or appropriate information from the manufacturer S4.

Jan 30, 2018 · Unlike European Medicine Agency (EMA) requirements, the addition of a finished product manufacturing site requires new registration and a complete dossier. To increase transparency with patients, information about registered medicine is available on the health authority website of the Philippines, Malaysia, Singapore. 10-12.