January 1, Journal article Open Access. The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. The attitudes and actions of Regulatory Affairs Professionals will condition the perceptions of the government officials to the company. Dossier is a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic.
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In , Brunei Darussalam joined its neighbors in the association. Vietnam has become member since , Laos and Myanmar since and Cambodia since These four new members are usually referred to as the CLMV group.
A Pharmaceutical Product Working PPWG was established to work on the details in the development of harmonization guidelines for technical procedures and requirements partially applicable to the ASEAN pharmaceuticals have been identified for harmonization - quality, efficacy, safety and administrative data.
While ASEAN was working on its harmonized pharmaceutical registration, another international collaboration for harmonization of pharmaceutical registration was taking place in parallel called the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH. It was established in and works for development for technical guidelines for registration of pharmaceutical products to achieve greater harmonization.
ASEAN Pharmaceutical Product  At the first PPWG meeting the terms of reference were agreed and it was decided that the topics selected for harmonization would be divided into safety, quality and efficacy to reflect the three criteria which would be the basis for approving medicinal products.
This means that same regulatory requirements apply for the registration of a medicinal product among the ASEAN member countries. The ACTD should serve as a locator for documentation that has been compiled for a marketing authorization application. It does not give any recommendations on the actual content of the dossier. It is a guide for preparation of the ACTD.
Series of guidelines for the implementation of the ATCR are being finalized. The ASEAN Standards and Quality Bulletin is regularly published with a view to ensure dissemination of information and promote transparency on standards, technical regulations and conformity assessment procedures in ASEAN member countries.
Regulatory Agencies. Drug Administration of Vietnam. Food and Drug Administration. Department of Drug, Food and Cosmetics. This guideline describes a CTD format that would significantly reduce the time and resources needed to compile applications for registration and in the future, would ease the electronic document submissions. The main points of divergence are in the content and format of the registration dossier.
Module 1 -Regional and Administrative Information. Contains documents that are specific to each region. This module is not part of CTD.
Basically consists of administrative documents like Application form, legal documents GMP, Licenses etc. Required for generics and New Drug. Module 2 - Overall Summary. This module summarizes the Module 3, 4 and 5. The summary provides reviewer the abstract of documents provided in the whole application.
For generics summary on Quality part only required. The documents related to Chemistry, manufacturing and Control of both Drug Substance and Drug Product is included in this module.
Non Clinical Study Reports — Data on pharmacologic, pharmacokinetic, and toxicological evaluation of the pharmaceutical product is provided. Not required for generics. Clinical Study Reports - A critical assessment of the clinical data and related reports is provided in this module. Not required for generics except Bioequivalence study. Subscribe to Pharmatutor Alerts by Email. Crack GPAT. Pharma News. Pharma Quiz.
Department of Health. Ministry of Health. Laos PDR. Part I. Module 3 - Quality. Part II. Module 4 - Safety. Part III. Module 5 -Efficacy.
ASEAN Common Technical Dossier (ACTD)
REGULATORY DOSSIER- ASEAN COMMON TECHNICAL DOCUMENT (ACTD) FOR ASEM COUNTRIES