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American Journal of Biological and Pharmaceutical Research

Volume 7, Issue 2, 2020
Mcmed International
American Journal of Biological and Pharmaceutical Research
Issn
2348 - 2176 (Print), 2348 - 2184 (Online)
Frequency
bi-annual
Email
editorajbpr@mcmed.us
Journal Home page
http://mcmed.us/journal/ajbpr
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Abstract
Title
A REVIEW ON OMAN DRUG REGULATORY POLICY AND eCTD SPECIFICATIONS
Author
Thabitha B*, Jyoshtna Devi K, Jayachandra Reddy P
Email
thabitha.bandela7@gmail.com
keyword
DGPA&DC, DP, DDC, GMP, INCB, INN, LCM, BM, OCR, MD5, MOH. DGPA&DC, DP, DDC, GMP, INCB, INN, LCM, BM, OCR, MD5, MOH. DGPA&DC, DP, DDC, GMP, INCB, INN, LCM, BM, OCR, MD5, MOH. DGPA&DC, DP, DDC, GMP, INCB, INN, LCM, BM, OCR, MD5, MOH.
Abstract
The review article describes the drug regulatory process of medicines in Oman. The aim of this document is to compile all relevant, existing information on the pharmaceutical sector and make it available to the public in a user-friendly format. Recently Oman MOH Introduced the electronic Common Technical Document format (eCTD) form for submitting the submissions instead of paper format. It provides assistance with the submission of regulatory information in eCTD to the Directorate General of Pharmaceutical Affairs & Drug Control (MOH-DGPA&DC). The document covers general guidance on how to organize electronic application information submitted to the directorate in accordance with eCTD specifications. Guidance on the information to be included in each section of the applications and submissions is based on the International Conference of Harmonization (ICH) and Oman MOH regulatory framework for drug approval. Applicants submitting eCTD applications must comply with this guidance documents as well as the "GCC Module 1 Specifications for eCTD" made available on the Ministry website.
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