![References
1. Syed, M. “Comparison of Regulatory Requirements for Generic Drugs
Dossier Submission in United States, Europe and Canada ’’ [Internet]
Cited [2018 Aug 31 ] Available from http://www.ijpacr.com/files/07-04-
2017/35.pdf
2. The International Conference on Harmonization.[Internet] [cited 2018
Aug 31]; Available from http//www.ich.org/cache/compo/276-254-1.html.
3. The ASEAN Common Technical Dossier (ACTD) for The Registration of
Pharmaceuticals for Human use. [Internet] [Cited 2018 Aug 31] Available
from http://asean.org/?static_post=asean-common-technical-dossier-actd](https://image.slidesharecdn.com/conceptofregulatedandnonregulatedmarkets-190817064414/85/Concept-of-regulated-and-non-regulated-markets-29-320.jpg)
![4. CDSCO Web site ,[Internet] Cited [ 2018 Aug 31] Available from http://cds
co.nic.in/forms/Default.aspx
5. Antony P and Cassandra M “Global pharmaceutical regulation: The challenge
of integration for developing state ’’ Cited [ 2018 Aug 31] Available from
https://globalizationandhealth.biomedcentral.com/articles/10.1186/s12992-
016-0208-2
6. Joes Luis Valverde “ Latin American Pharmaceutical Overview ’’
[Internet]Cited [2018 Aug 31] Available from
https://www.researchgate.net/publication/288221607/](https://image.slidesharecdn.com/conceptofregulatedandnonregulatedmarkets-190817064414/85/Concept-of-regulated-and-non-regulated-markets-30-320.jpg)
![7. CDSCO India, Guidance for Industry [Internet] [Cited 2018 Aug 31]
Available from http://www.cdsco.nic.in/writereaddata/CDSCO-
GuidanceForIndustry.pdf
8. M Sravani et.al . “Regulatory Aspects of Pharmaceuticals in Gulf Co-
operation Council Countries’’ [Internet] [Cited 2018 Sep 1] Available
from http://www.ijpacr.com/files/21-07-2017/01.pdf](https://image.slidesharecdn.com/conceptofregulatedandnonregulatedmarkets-190817064414/85/Concept-of-regulated-and-non-regulated-markets-31-320.jpg)
![9. Jitendra Kumar Badjatya “ Overview of Drug Registration Requirements
for Pharmaceuticals in Emerging Markets”[ Internet] [Cited 2018 Sep1]
Availablefromhttps://www.researchgate.net/publication/303279229/downl
oad
10. Alistair Davidson “ Regulatory Strategy for the Emerging Markets Far
East, Africa, Middle East ,Latin America’’ [Internet] [Cited 2018 Sep 1]
Available from
https://embed.topra.org/.../reg._strategy_for_the_emerging_markets__a.da
vidson.pdf](https://image.slidesharecdn.com/conceptofregulatedandnonregulatedmarkets-190817064414/85/Concept-of-regulated-and-non-regulated-markets-32-320.jpg)
Concept of regulated and non regulated markets
- 1. Harshith N Concept of Regulated and Emerging Markets
- 2. Need to Study Regulated and Emerging Regulated Market • To Know about the Categorization of Markets • To Know about the Authorities of both Regulated and Emerging Markets • To Know about the Economic Importance of Regulated and Emerging Markets
- 3. Categorization of Pharmaceutical Markets • Regulated Market • Non Regulated/Semi Regulated/Emerging Market/ROW • Domestic
- 4. List of Regulated Countries and their Agencies Country Regulatory Agency Website Unites States of America https://www.fda.gov/ United Kingdom https://www.gov.uk/gove rnment/organisations/me dicines-and-healthcare- products-regulatory- agency Australia https://www.tga.gov.au/
- 6. Requirements for Regulated Markets • Site Registration • Plant GMP Approval • Single Registration Process • Multiple Registration Process • eCtd • Bioequivalence Reports
- 7. Challenges in Regulated Markets • Stringent Regulatory Compliance • Patents • Lack of senior level talent in top level QA, IP protection • Changing regulations and increasing inspection by the Authority • Warning Letters and Queries
- 8. List of Emerging Markets
- 9. LATHAM Countries Brazil, Argentina, Mexico, Colombia, Chile, Peru ASEAN Countries Myanmar, Laos, Thailand, Cambodia, Singapore, Indonesia, Malaysia, Philippines, Brunei
- 10. CIS countries Armenia,Azerbaijan, Belarus,Kazakhstan, Kyrgyzstan,Moldova,Russia, Tajikistan,Uzbekistan, Turkmenia, Ukraine African Countries Algeria, Benin, Burkina Faso, Cameroon, Chad, Cost de Ivory, Ethiopia, Gabon, Ghana, Kenya, Madagascar, Mali, Mauritiana, Morocco, Mozambique, Nigeria, Rawanda, Senegal, Tanzania, Togo,Uganda, Zambia, Zimbawe
- 11. GCC Countries Kuwait, Bahrain, Qatar, Saudi Arabia,UAE,Oman,Yemen NEPAL SRILANKA Nepal , Srilanka
- 12. Requirements for Emerging Markets • Site Registration • Plant GMP Approval • Single Registration Process • CTD/ACTD/Country Specific • Regional Variations regarding Administrative Documents
- 13. Challenges in Emerging Markets • Variation in Guidelines depending on Country Requirements • Extending Support to Company's Marketing Team in Time • Agencies Even from Emerging Markets getting Stringent • Future Emergence of eCTD • Queries • Growing Commercial Importance
- 14. Domestic Market
- 16. Requirements of Domestic Market • Site Registration • Plant GMP Approval • Single Registration Process • CTD • CDSCO also looks into other Various applications
- 17. Economic Importance of Regulated Markets
- 18. • Regulated Marketed Considered to be Cash Cows for Pharmaceutical Industry • Profitability is far high when Compared to Emerging Markets • Export of Pharmaceuticals in turns boost Country’s Economy • Building Operational Excellence • India is Largest Exporter of Generic Drugs
- 19. Economic Importance of Emerging Markets
- 20. • Emerging Markets enables to Register larger Number of Products • Enables to Operate Comparatively easier Significant amount of Profits • Lower Production Costs When Compared to the Regulated Markets • Covers Significant of the Worlds Population
- 21. Economic Importance of Domestic Market
- 22. • India’s Population is Nearly 1/5th of the Worlds Population • Lower Production, Labor Cost Which enables to Make Huge Margin of Profits • Business Operations in Domestic Market is Easier • Over the Counter Drugs have a Stronger Potential in India • Cost of Approval is Less in Domestic Market
- 23. Need for Harmonization between Regulated and Emerging Markets
- 24. • To Make the Regulatory Compliance easier • Cost effective avoids duplication of documents • Build Stronger quality systems in order to achieve full compliance • Smoother Business and Marketing Operations • Approval Rate of Pharmaceuticals would be high
- 25. Exports Country Value Share United States $3.8 billion 32.9% South Africa $461.1 million 3.9% Russia $447.9 million 3.8%
- 26. United Kingdom $444.9 million 3.8% Nigeria $385.4 million 3.3% Kenya $233.9 million 2% Tanzania $225.2 million 1.9%
- 27. Brazil $212.7 million 1.8% Australia $182.1 million 1.6% Germany $178.8 million 1.5%
- 28. • THANK YOU
- 29. References 1. Syed, M. “Comparison of Regulatory Requirements for Generic Drugs Dossier Submission in United States, Europe and Canada ’’ [Internet] Cited [2018 Aug 31 ] Available from http://www.ijpacr.com/files/07-04- 2017/35.pdf 2. The International Conference on Harmonization.[Internet] [cited 2018 Aug 31]; Available from http//www.ich.org/cache/compo/276-254-1.html. 3. The ASEAN Common Technical Dossier (ACTD) for The Registration of Pharmaceuticals for Human use. [Internet] [Cited 2018 Aug 31] Available from http://asean.org/?static_post=asean-common-technical-dossier-actd
- 30. 4. CDSCO Web site ,[Internet] Cited [ 2018 Aug 31] Available from http://cds co.nic.in/forms/Default.aspx 5. Antony P and Cassandra M “Global pharmaceutical regulation: The challenge of integration for developing state ’’ Cited [ 2018 Aug 31] Available from https://globalizationandhealth.biomedcentral.com/articles/10.1186/s12992- 016-0208-2 6. Joes Luis Valverde “ Latin American Pharmaceutical Overview ’’ [Internet]Cited [2018 Aug 31] Available from https://www.researchgate.net/publication/288221607/
- 31. 7. CDSCO India, Guidance for Industry [Internet] [Cited 2018 Aug 31] Available from http://www.cdsco.nic.in/writereaddata/CDSCO- GuidanceForIndustry.pdf 8. M Sravani et.al . “Regulatory Aspects of Pharmaceuticals in Gulf Co- operation Council Countries’’ [Internet] [Cited 2018 Sep 1] Available from http://www.ijpacr.com/files/21-07-2017/01.pdf
- 32. 9. Jitendra Kumar Badjatya “ Overview of Drug Registration Requirements for Pharmaceuticals in Emerging Markets”[ Internet] [Cited 2018 Sep1] Availablefromhttps://www.researchgate.net/publication/303279229/downl oad 10. Alistair Davidson “ Regulatory Strategy for the Emerging Markets Far East, Africa, Middle East ,Latin America’’ [Internet] [Cited 2018 Sep 1] Available from https://embed.topra.org/.../reg._strategy_for_the_emerging_markets__a.da vidson.pdf