We are writing this article to help new students and fresh graduates from pharmacy schools and fresher’s in pharmaceutical industry around the world . We get many email requests for providing a comprehensive detail information about worlds pharmaceutical manufacturing regulatory agencises or FDA’S.
In today’s post the section is divided in brief in two parts
1.Pharmaceutical industries organizations around the world.
2.Pharmaceutical regulatory agencies authorities around the world.
1.Pharmaceutical industries organizations around the world.
There are some organizations around the world which are formed to help pharmaceutical industry and regulatory authorities, they are associated with pharmaceutical industry regulatory affairs , they are formed to serve a common purpose all togather to serve pharmaceutical industry for their interest and to satisfy FDA compilances all togather , these activities comprises of advising for current good manufacturing guidelines , regulations , FDA inspections and compliances , registration of pharmaceutical products and so on, some of them are reginal organisations.
1) (ICH ): is short form of “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use” (ICH).
This is a organization which brings together regulatory authorities in Europe and peoples from industry , they discuss scientific aspects of pharmaceutical regulatory guidelines , and its application and implementation.
The guidelines define quality, safety, efficacy & related aspects for developing and registering new medicinal products in Europe, Japan and the United States.
1.European Confederation of Pharmaceutical Entrepreneurs AISBL
This organization is founded in 2008 it is a European pharmaceutical industrial entrepreneurs association.
2.European Federation of Pharmaceutical Industries and Associations (EFPIA)
This organization is founded in 1978 represents the research based pharmaceutical industry in Europe.
3.International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
This organization is a global non-profit NGO which represents research-based pharmaceutical, biotech and vaccine manufacturing companies and national industry associations in developed and developing countries.
4.The Japan Pharmaceutical Manufacturers Association or JPMA
This organisation represents the research-based pharmaceutical industry of Japan.
5.Pharmaceutical Research and Manufacturers of America:(PhRMA)
Established in 1958, this is a group which represents the pharmaceutical research and biotechnology companies from United States.
6.OECD
Organization for Economic Collaboration and Development They includes 30 member countries covers economic and social issues in areas of health care.
7.EMEA
European Medicines Agency (EMEA), This is a decentralized body of European Union headquartered in London, they give guidelines for inspections and general reporting and all aspects of human & veterinary pharmaceuticals in the European Union
2.Pharmaceutical Regulatory Authorities in worlds (World’s FDA’S )
1.WHO
World health organization guidelines are the most sought regulatory requirements, and GMP guidelines , to qualify for sale of medicine in any country a pharmaceutical company has to get first WHO GMP certification done for its manufacturing facility.
2.US FDA
This is USA’S FDA , this is worlds one of modern FDA , they are constantly into improving quality and reliability of medicines of which are sold in USA , they are the best in taking utmost care of their citizens health.
The conditions and regulations being implemented are the best in world.
3.Central Drugs Standard Control Organization ( CDSO )
Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
Indian regulatory authority which regulates pharmaceutical manufacturing , approval for sale etch throgh state and reginal FDA’S.
Drug price control
National pharmaceutical prising authority Goverment of india.
This regulatory agency takes care that the prise of medicines are in control , they are affordable for poors too, irrelevant prising is taken care off.
3.TGA
Therapeutic Goods Administration, the Australian pharmaceutical regulatory body.
4.South Africa
The department of Health, South Africa.
5.Codex Alimentarius
Codex Alimentarius Commission under the Joint FAO / WHO Food Standards Programme.
6.MHRA
Medicines and Healthcare products Regulatory Agency (MHRA), This organization is a regulatory agency responsible for ensuring efficacy and safety of medicines and medical devices in the UK.
7.Health Canada
This is a regulatory agency of Canada. Health Canada, Federal Department responsible for health related issues in Canada.
8.Thai FDA
Thai Food and Drug Administration
9.HSA, Singapore
Health Sciences Authority (HSA), the regulatory body of Singapore.
10.DOH, Philippines
The Department of Health, Philippines.
11.Medsafe, New Zealand
Medsafe, New Zealand Medicines and Medical Devices Safety Authority.
12.NPCB, Malaysia
National Pharmaceutical Control Bureau, Malaysia.
13.DGMP, Belgium
Directorate-General Medicinal Products, Belgium.
14.BfArM, Germany
Federal Institute for Drugs and Medical Devices, Germany
15.SwissMedic
Swiss regulatory agency
16.MPA, Sweden
Medical Products Agency, Sweden.
17.NAFDAC, Nigeria
The National agency for Food Administration and Control (NAFDAC), Nigeria.
We might have missed one or two things , we welcomereders to contribute to this post , we will honour the update.
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