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Kamaraj, R.
- Marketing Approval for Medical Devices in European Union
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Authors
Affiliations
1 Department of Pharmaceutical Regulatory Affairs, SRM Institute of Science and Technology, SRM College of Pharmacy, Kattankulathur-603203 Dist – Kancheepuram, IN
1 Department of Pharmaceutical Regulatory Affairs, SRM Institute of Science and Technology, SRM College of Pharmacy, Kattankulathur-603203 Dist – Kancheepuram, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 1 (2019), Pagination: 391-395Abstract
The demand of medical devices has risen globally, especially in Europe. The devices regulated in Europe must ensure the safety and effectiveness of these products. There are various principles to approve the medical devices in the European market. The biggest companies are in Germany (27%), UK (11%), Italy, Switzerland, Spain and France (16%). The Europe has very good gobal impact in medical device marketing. The classification is based upon risk management, the medium and high risk requires the conformity assessment (CE marking) done by Notified bodies. There are four levels of classification of devices. Various EU directives that has impact on medical devices. International medical device regulatory forum (IMDRF), is followed by regulatory department of countries like Austrila, Brazil, Canada, China, EU, Japan, the United States, and WHO. The approved medical devices in European market must ensure the best protection of patient health. The development timelines for Noval drug and chemical entity take much longer time compared to medical devices. There are about 500,000 life supporting machines in which 20,000 are of generic group. Various rules on clinical evaluation and clinical investigation help in strengthening the regulatory system in Europe. To explore in marketing level premarket testing and postmarked vigilance is required.Keywords
Medical Devices, CE Marking, Notified Bodies, European Market, IMDRF.
References
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- Christa Alenstter. “EU and member state medical devices regulation”, International Journal of Technology Assessment in Health Care, 01/2003.
- European Commission. Classification of medical devices (MEDDEV 2.4/1 Rev. 9). June 2010.
- European Council. Directive 93/42/EEC concerning medical devices. June 14, 199.
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- European Commission. Medical devices: guidance MEDDEVs. June 10, 2011.
- CE marking: the fast route to compliance in the European Union. Hertfordshire, United Kingdom, BSI.
- Schreyogg J, Baumler M, Busee R. Balancing adoption and affordability of medical devices in Europe. Health Policy 2009;92:218-224.
- Teysseyre, Patricia. “European Union: Medical Device Regulatory System”, Hamdbook of Medical Device Regulatory Affairs in Asia, 2013.
- Global Medical Device Nomenclature (GMDN) Agency, 2010.
- CE marking: the fast route to compliance in the European Union. Hertfordshire, United Kingdom, BSI (http;/www/bsigroup.com/upload/product%20Services/About%20CE%20marking/CE Brochure) 2010 pdf.
- European Commission. Medical devices: Council of the European Union. Council Directive 2007/47/EC. September 21, 2007.
- Commission decision 2010/227/EU of 19 April 2010 on the European Databank on medical devices (EUDAMED). 2010 http://eurdlex.europaeu/LexUriServ.do?uri=OJ:L2010:1020045:0048:EU:PDF,last accessed 2-1-2015.
- Registration and Regulatory Requirements of Generic Drugs Marketing Authorization in “BRICS” Countries
Abstract Views :165 |
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Authors
Affiliations
1 Department of Pharmaceutical Regulatory Affairs, SRM Institute of Science and Technology, SRM College of Pharmacy, Kattankulathur-603203 Dist–Kancheepuram, IN
1 Department of Pharmaceutical Regulatory Affairs, SRM Institute of Science and Technology, SRM College of Pharmacy, Kattankulathur-603203 Dist–Kancheepuram, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 3 (2019), Pagination: 1403-1408Abstract
The comparative study of generic drug registration in BRICS, was to find out the differences among the guidelines. “BRICS” mainly refers to Brazil, Russia, India, china and South Africa. The regulatory requirements of each country is different from each other, “BRICS” has the fastest growing and largest emerging markets which shows the positive growth in the pharmaceutical companies. The medical regulatory system in the BRICS countries is increasing in the medical profession to safeguard and promote the medicine. The BRICS countries together is consider as important emerging economics, which has 40% of world population. To develop the universal health coverage, The BRICS countries of national institution agreed to join hands with (WHO), world health organization.Keywords
Regulatory Requirements, Registration Process, Brazil, Russia, India, China and South Africa (BRICS), Generic Products.References
- Marketing Authorization Available from: http://en.wikipedia.org/ wiki/Marketing authorization
- Brazilian National Health Vigilance Sanitaria Available from:
- http://www.ghtf.org/meetings/conferences/9thconference/presentations/latinamerican/waynebrodbeskow.pdf
- National Health Surveillance Agency: http://www.anvisa.gov.br/hotsite/genericos/legis/leis/6360_e.htm
- National Health Surveillance Agency: Resolution no nº 3.675 http://www.anvisa.gov.br/eng/legis/resol/136_03_ redc_e.htm
- National Health Surveillance Agency: http://www.puntofocal.gov.ar/notificotros_miembros/bra226_t.pdf
- National Health Surveillance Agency Legislation Resolution- RE nº 478 http://www.silvademoraes.com.br/site_ingles/jurisprudence/food_drugs_itens.html Drug Registration and Labelling in Brazil: http://www.princeton.edu/~ota/ disk1/1993/9321/932111.PDF
- Russian federation [Online]: Available from: www.roszdravnadzor.ru.
- Registration of Pharmaceutical Products in Russia: http://pharmareg.ru/upload/ReportAChorichFrankfurt.pdf
- Drug regulatory requirements in Russia [Online]: www.pharmabiz.com/article/detnews.asp
- G. Sai Hanuja, B. Sai Kumari, M. V. Nagabhushanam, D. Nagarjuna Reddy, Brahmaiah Bonthagarala, Regulatory Requirements for Registration of Generic Drugs in “BRICS” Countries, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6, Vol. 6, November-December 2016,20-40.
- B. Sai Kumari, G. Sai Hanuja, M.V. Nagabhushanam, D. Nagarjuna Reddy, Brahmaiah Bonthagarala, Current Regulatory Requirements for Registration of Medicines, Compilation and Submission of Dossier in Australian Therapeutic goods Administration, International Journal of Advanced Scientific and Technical Research ISSN 2249-9954, Issue 6 volume 6, November-December 2016, 144-157. 15.Shaik Salman Basha, S. M. Shakeel, M. V. Nagabhushanam, D. Nagarjuna Reddy, Brahmaiah Bonthagarala, The Assessment of Current Regulatory Guidelines for Biosimilars- A Global Scenario, World Journal of Pharmaceutical Research, ISSN 2277– 7105, volume 6, Issue 1, 351-369.
- S.M. Shakeel, Shaik Salman Basha, M.V. Nagabhushanam, D. Nagarjuna Reddy, Brahmaiah Bonthagarala, Comparison of Regulatory Requirements for Generic Drugs Dossier Submission in United States and Canada, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6,Vol. 6 , November-December 2016, 1-19.
- Mounica N.V.N., Sharmila Reddy V, Anusha S, Evangeline L, Nagabhushanam M.V., Nagarjunareddy D, Brahmaiah B, Scale up and Post Approval Changes (SUPAC) Guidance for Industry: A Regulatory Note, ISSN: 2321 – 6794, DOI:https://doi.org/10. 22270/ijdra.v5i1.192, International Journal of Drug Regulatory Affairs; 2017, 5(1), 13-19.
- Sharmila Reddy V, Mounica N.V.N., Anusha S, Evangeline L, Nagabhushanam M.V., Nagarjunareddy D, Brahmaiah B, Regulatory Requirements of Similar Biologics for Marketing Authorization in India, ISSN: 2321–6794, DOI:https://doi.org /10.22270/ijdra.v5i1.193, International Journal of Drug Regulatory Affairs; 2017, 5(1), 20-24.