This recommended format in the CTD guideline for registration applications has become widely accepted by regulatory authorities both within and beyond the ICH Regions. The International Conference on Harmonization (ICH) process has considerably harmonized on the organization of the registration of documents with the issuance of the Common Technical Document (CTD) guideline. It is more commonly called as New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in European Union (EU) and other countries as simply Registration Dossier. “Registration Dossier” of the pharmaceutical product is a document that contains all technical data (administrative, quality, nonclinical, and clinical) of a pharmaceutical product to be approved / registered / marketed in a country. Process of critiquing and assessing the dossier of pharmaceutical product containing its detailed about administrative, chemistry, preclinical & clinical information and the permission granted by the regulatory agencies of a country with a view to support its marketing or approval in a country is called as “Marketing approval or Registration” ,“Marketing Authorization or “ Product Licensing”. designated to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “Pharmaceutical product for human use”. Any formulation is prepared for human use i.e. How to cite this article: Gautam VK, Mohamad I A Study of procedures for Dossier Preparation and their marketing authorisation in different countries of selected drug(s) PharmaTutor 2017 5(10) 8-22ĭossier The word 'Dossier' has the english meaning as a collection or file of documents on the particular subject, especially a file containing detailed information about a person or a topic. Also if both guidelines of CTD and ACTD can be harmonized then differences and variation between both guidelines can be minimized. ACTD act as bridge between regulatory requirements of developed and developing countries. ICH-CTD followed by ICH countries as well as low economical or developing countries where as ACTD is followed by ASEAN countries. There are basically two formats for dossier preparation i.e. This process is governed and permitted by Drug Regulatory Authority of a particular country and process is called as NDA in USA, MAA in EU and other countries as simply Registration Dossier. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data. 1Executive in Drug Regulatory Affairs Department East African (India) Overseasġ 120 Suncity Business Tower,Sector-54, Gurgaon-122002 (Haryana).ĢResearch Associate Jubilant Chemsys Ltd.ĢD-12, Sector 59, Noida, Uttar Pradesh, IndiaĪbstract : Dossier is a collection of documents on the particular subjects.
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