A critical view of harmonization of regulatory requirements for Generic Drug approval submissions in ASEAN countries
Abstract
To ensure quality, efficacy, and safety of drugs is the prime objective of any country and respective drug regulatory authority. Countries have their own regulatory setup to ensure the proper execution of drug regulatory guidelines in their country. There are several regional organization in world, ASEAN is one of them. It is Association of Southeast nations. ASEAN is very well representing its countries on global platform. The step of harmonization of drug regulatory guidelines by ASEAN is seen as major step taken by an Asian regional organization.
ASEAN is an emerging market and every country has its own needs. As research and development sector is only developed in Singapore in ASEAN region so, generics emerge as a tool for other countries to fulfill UHC goals and Vision 2020 ASEAN. Every country has the different procedure for generic drug registration application approval. To clearly understand the procedure of generic drug registration application approval process we have gone through various guidelines and literature. There are 10 members in ASEAN i.e. Singapore, Malaysia, Thailand, Indonesia, Philippines, Brunei Darussalam, Laos PDR, Myanmar, Vietnam, and Cambodia. Each one’s generic drug approval process, requirements and effects on pharmaceutical trade after implementation of ACTD is explained in this research work. This research work also includes the statistical analysis and suggestions on how other countries and regional organization follow the model of ASEAN for drug regulatory harmonization procedure.
Downloads
References
2. WHO | World Health Organization [Internet]. WHO; 2018 [cited 2019 Jan 11]. Available from:
http://www.who.int/
3. Handoo S., Khera D., Nandi P., Sahu S., Arora V. A comprehensive study on regulatory requirements for development and filing of generic drugs globally. International Journal of Pharmaceutical Investigation. 2012; 2(3): 1-12.
4. Rodriguez V., Soeparwata A. ASEAN benchmarking in terms of science, technology, and innovation from 1999 to 2009. Scientometrics. 2012; 92(3): 549-73.
5. World Bank | World Bank [Internet]. World Bank; 2019 [cited 2019 Jan 11]. Available from:
www.worldbank.org/
6. Pankaj K., Duggal E., Budhwar P., Badjatiya J.K. Marketing authorization of generic drug: global issue and challenges International Journal of Drug Regulatory Affairs. 2013; 1(3): 1-6.
7. APAC Regulations and Approvals Expert Working Group. Identification and Clarification of the differences in Regulatory requirements between Asian Economies. Tokyo, Japan: Asia Partnership Conference of Pharmaceutical Associations (APAC); 2013: 1-118.
8. ASEAN. ACTR., [Internet]. The ASEAN Secretariat: Jakarta; 2016 Dec [cited 2019 Jan 15]. Available from:
http://asean.org/storage/2017/03/67.-December-2016-ACTR.pdf
9. Vaseem Akram M., Venketeshwarlu B., Ramaiah M., Nagabhushanam, Nagaarujuna D. Regulatory requirements for the registration of generic solid orals in USA, Singapore, Malaysia, and Thailand. JGTPS. 2014; 5(4):2225-32
10. The ASEAN Secretariat. ASEAN Statistical Yearbook. Jakarta: The ASEAN Secretariat; 2017: 1-280.
11. The ASEAN Secretariat. ACTD. Jakarta: The ASEAN Secretariat; 2016 .p. 4-198.
12. EMEA. CTD. London: EMEA; 2003: 1-26.
13. Health and Healthcare Systems in Southeast Asia - United Nations University [Internet]. Unu.edu 201: Japan; 2012 Apr 5 [cited 2019 Jan 19]. Available from:
https://unu.edu/publications/articles/health-and-healthcare-systems-in-southeast-asia.html
14. ASEAN Statista. [Internet]. statista; 2018 [cited 2019 Jan 14]. Available from:
https://www.statista.com/statistics/796245/gdp-of-the-asean-countries/.
15. ASEAN [Internet]. ASEAN: Thailand; 2017 [cited 2019 Jan 14]. Available from:
https://asean.org/resource/statistics/
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
