Quick Access to Regulatory Bodies Across the Globe

Lakshya Untwal  's picture
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Here are some links to essential information for achieving global market presence…

INTERNATIONAL :

International Conference on Harmonization (ICH):

ICH Home Page

ICH Guidelines - Quality, Safety, Efficacy, Multidisciplinary, including Common Technical Document (CTD) and Electronic Common Technical Document: (eCTD)

World Health Organization (WHO):

WHO: Home Page

WHO: Medicines (Medicines Policy and Standards…)

WHO: Medicines: Quality Assurance - Links to WHO Guidelines, including WHO GMP

WHO: Certification Scheme for the Quality of Pharmaceuticals

WHO: Prequalification Programme

World Trade Organization (WTO):

WTO: Home Page

WTO: TRIPS Gateway (Trade-Related Aspects of Intellectual Property Rights)

World Intellectual Property Organization (WIPO):

WIPO: Home Page

WIPO: Patent Search

Free Patents Online:

Free Patent Search, Free Patent PDF Downloads, Free Intellectual Property Alerts

UNITED STATES OF AMERICA (USA) :

United States Food and Drug Administration (US FDA):

US FDA: Home Page

US FDA: Center for Drug Evaluation and Research (CDER)

US FDA: CDER Guidance Documents

US FDA: Center for Biologics Evaluation and Research (CBER)

US FDA: CBER Guidance Documents

US FDA: Abbreviated New Drug Application (ANDA) Process for Generic Drugs

US FDA: Current Good Manufacturing Practices (cGMP) Regulations (21 CFR Parts 210 and 211)

US FDA: Drug Master Files (DMF guidance and DMF Database)

US FDA: Center for Devices and Radiological Health (CDRH)

US FDA: CDRH Regulatory and Marketing Advice for Medical Devices

OTHER AMERICAN COUNTRIES :

CANADA:

Health Canada: Home Page (in English and French)

Health Canada: Health Products and Food Branch

Health Canada: Legislation and Guidelines – Drugs and Health Products – Main Page

Health Canada: Therapeutic Products Directorate

LATIN AMERICA:

Argentina: Ministry of Health (in Spanish)

Argentina: National Administration of Drugs, Foods and Medical Technology (in Spanish)

Bolivia: Ministry of Health and Social Welfare (in Spanish)

Chile: Health Ministry (in Spanish)

Chile: Institute of Public Health (in Spanish)

Colombia: Ministry of Health (in Spanish)

Colombia: INVIMA  Instituto Nacional de Vigilancia de Medicamentos y Alimentos (in Spanish)

Ecuador: Ministry of Public Health (in Spanish)

El Salvador: Ministry of Public Health and Social Assistance (in Spanish)

Guatemala: Ministry of Health (in Spanish)

Guyana: Ministry of Health

Guyana: National Bureau of Standards

Jamaica: Ministry of Health

Mexico: Ministry of Health (in Spanish)

Mexico: Federal Commission for Protection against Health Risks (in Spanish)

Nicaragua: Ministry of Health (in Spanish)

Panama: Ministry of Health (in Spanish)

Peru: Ministry of Health (in Spanish)

Peru: General Directorate of Pharmaceuticals, Devices and Drugs (in Spanish)

Trinidad and Tobago: Ministry of Health

Trinidad & Tobago: Bureau of Standards

Uruguay: Ministry of Public Health (in Spanish)

EUROPEAN UNION (EU) :

European Medicines Agency (EMEA):

EMEA : Home Page

EudraLex : The Rules Governing Medicinal Products in the European Union (including Notice to Applicants, Good Manufacturing Practices, and other Guidelines for Human and Veterinary Medicinal Products)

European Directorate for the Quality of Medicines and Healthcare (EDQM):

EDQM: Home Page

EDQM: Certification of Pharmaceutical Substances – News and General Information on APIs and Excipients, Certificate of Suitability (CEP) Database

EUROPEAN NATIONAL AUTHORITIES :

GERMANY:

Germany: Ministry of Health

Germany: Federal Institute for Drugs and Medical Devices (BfARM)

Germany: Robert Koch Institute (in German)

Germany: Paul Ehrlich Institute (in German)

Germany: Federal Institute for Risk Assessment

UNITED KINGDOM:

UK: Department of Health

UK: Health Protection Agency

UK: Medicines and Healthcare products Regulatory Agency

UK: National Institute for Biological Standards and Control

UK: Veterinary Medicines Directorate

FRANCE:

France: Ministry of Health (in French)

France: Sanitary Safety of Health Products Agency  - AFSSAPS (in French)

France: National Agency for Veterinary Medicinal Products

ITALY:

Italy: Ministry of Health (in Italian)

Italy: National Institute of Health

SPAIN:

Spain: Ministry of Health and Consumption

Spain: Spanish Agency of Medicinal Products

SWITZERLAND:

Switzerland: Federal Office of Public Health

Switzerland: Agency for Therapeutic Products (SWISSMEDIC)

Switzerland: Federal Veterinary Office

OTHER EUROPEAN NATIONAL AUTHORITIES:

Austria: Federal Ministry of Labour, Health and Social Affairs (in German)

Belgium: Ministry of Social Affairs, Public Health and the Environment

Belgium: Pharmaceutical Inspectorate

Bulgaria: Ministry of Health (in Bulgarian)

Bulgaria: Drug Agency

Croatia: Ministry of Health

Czech Republic: Ministry of Health (in Czech)

Czech Republic: State Institute for Drug Control

Denmark: Ministry of Health

Denmark: Medicines Agency

Denmark: Veterinary and Food Administration

Estonia: Ministry of Social Affairs

Estonia: State Agency of Medicines

Finland: Ministry of Social Affairs and Health

Finland: National Agency for Medicines

Greece: Ministry of Health and Welfare (in Greek)

Greece: National Organization for Medicines

Hungary: Ministry of Health

Hungary: National Institute of Pharmacy

Iceland: Ministry of Health and Social Security

Iceland: Medicines Control Agency

Ireland: Department of Health and Children

Ireland: Medicines Board

Latvia: State Agency of Medicines

Lithuania: State Medicines Control Agency

Luxembourg: Ministry of Health (in French)

Malta: Ministry of Health

Netherlands: Ministry of Health, Welfare and Sport

Netherlands: Medicines Evaluation Board

Norway: Ministry of Health and Care Services  

Norway: Norwegian Medicines Agency (in Norwegian and English)

Poland: Ministry of Health and Social Security (in Polish)

Poland: National Medicines Institute

Portugal: Ministry of Health (in Portuguese)

Portugal: National Institute of Pharmacy and Medicines (in Portuguese and English)

Romania: Ministry of Health and the Family (in Romanian)

San Marino: Ministry of Health and Social Security (in Italian)

Slovak Republic: Ministry of Health (in Slovak and English)

Slovak Republic: State Institute for Drug Control

Slovak Republic: State Veterinary and Food Administration (in Slovak)

Slovenia: Ministry of Health

Sweden: Medical Products Agency (in Swedish and English)

Turkey: Ministry of Health (in Turkish and English)

Ukraine: Ministry of Health (in Ukrainian, English and Russian)

BRAZIL, RUSSIA, INDIA AND CHINA (BRIC) :

BRAZIL:

Brazil: Ministry of Health (in Portuguese)

Brazil: National Health Surveillance Agency (ANVISA)

Brazil: Oswaldo Cruz Foundation

RUSSIAN FEDERATION:

Russian Federation: Mednet  (in Russian)

Russian Federation: Ministry of Health and Social Development (in Russian)

INDIA:

India: Ministry of Health and Family Welfare

India: Central Drug Standards Control Organisation (CDSCO)

India: Drugs & Cosmetic Act & Rules (PDF, 8.76 MB)

India: Notifications of Amendments to the Drugs & Cosmetic Act & Rules

India: Good Manufacturing Practices – Schedule M (PDF, 280 KB)

India: Good Clinical Practice Regulation – Schedule Y

India: Guidelines for Import and Manufacture of Medical Devices

India: List of State Drugs Control Organizations

CHINA:

China: General Administration of Quality Supervision, Inspection and Quarantine

China: Ministry of Health (in Chinese)

China: State Food and Drug Administration (SFDA)

China: National Institute for the Control of Pharmaceutical and Biological Products (in Chinese)

ASIA – PACIFIC :

JAPAN:

Japan: Ministry of Health, Labour and Welfare (MHLW)

Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

AUSTRALIA AND NEW ZEALAND:

Australia New Zealand Therapeutic Products Authority (ANZTPA)

(This project is on hold for now, but the site has a lot of useful information)

Australia: Department of Health

Australia: Therapeutic Goods Administration (TGA)

Australia: Pesticides & Veterinary Medicines Authority (APVMA)

New Zealand: Ministry of Health

New Zealand: Medicines and Medical Devices Safety Authority (MEDSAFE)

OTHER ASIA-PACIFIC NATIONAL AUTHORITIES:

Bangladesh:Ministry of Health And Family Welfare

Brunei: Ministry of Health

Fiji: Ministry of Health

Hong Kong: Department of Health

Indonesia: Ministry of Health

Korea: Food and Drug Administration (KFDA)

Malaysia: Ministry of Health

Malaysia: National Pharmaceutical Control Bureau

Nepal: Ministry of Health and Population

Nepal: Department of Drug Administration

Pakistan: Ministry of Health Portal

Pakistan: Drugs Control Organization

Papua New Guinea: Department of Health

Philippines: Department of Health

Singapore: Ministry of Health

Singapore: Health Sciences Authority

Singapore: Agri-food and Veterinary Authority

Sri Lanka: Ministry of Health

Taiwan: Department of Health

Taiwan: National Laboratories of Foods and Drugs

Thailand: Ministry of Public Health (in Thai)

Thailand: Food and Drug Administration

Vietnam: Ministry of Health

MIDDLE EAST :

Bahrain: Ministry of Health

Israel: Ministry of Health

Israel: Ministry of Health – Pharmaceutical Administration

Jordan: Ministry of Health

Lebanon: Ministry of Public Health 

Palestinian Authority: Ministry of Health

Saudi Arabia: Ministry of Health

United Arab Emirates: Ministry of Health

United Arab Emirates: Federal Department of Medicines and Pharmacy Control United Arab Emirates: Ministry of Health

United Arab Emirates: Federal Department of Medicines and Pharmacy Control

AFRICA:

REPUBLIC OF SOUTH AFRICA:

South Africa: Department of Health

South Africa: Medicines Control Council (MCC) - Links to all Guidelines for Licensing, Registration, GMP, etc), are listed under “Documents” on this page.

OTHER AFRICAN NATIONAL AUTHORITIES:

Botswana: Ministry of Health

Ghana: Ministry of Health

Kenya: Ministry of Health

Maldives: Ministry of Health

Mauritius: Ministry of Health & Quality of Life

Morocco: Ministry of Public Health (in French)

Namibia: Ministry of Health and Social Services

Senegal: Ministry of Health, Hygiene and Prevention (in French)

Swaziland: Ministry of Health and Social Welfare

Tanzania: Ministry of Health

Tunisia: Ministry of Public Health (in French)

Tunisia: Office of Pharmacy and Medicines (in French and Arabic)

Uganda: Ministry of Health 

Source:

http://www.pharmalliance.com/useful_links.html

http://www.globepharm.org/links/resource_agencies.html

http://www.pharmainfo.net/regulatory-zone/worldwide-regulatory-agencies

http://www.pharmainfo.net/regulatory-zone/pharmacopeia-resources

Nikhil Bhatwadekar's picture

Keep it up

4

keep on continuing such valuable links

Lakshya Untwal  's picture

Re: Keep it up

Dear Mr. Nikhil,
I'll try to keep posting such weblogs till you all like & reply with such passionate manner. I will definetly try to give my maximum inputs for our community.

Quick Access to Regulatory Bodies Across the Globe

1

Dear Lakshya Untwal,

I would like everyone here to know that the links you have posted on this blog have been copied and pasted directly from the "Useful Links" page of our website, www.pharmalliance.com

We have spent a lot of time and effort in compling these links for the benefit of the pharmaceutical industry worldwide.

While we have absolutely no objections to this information being widely disseminated among pharmaceutical professionals, we would have appreciated a line acknowledging the source of this information, rather than making it appear that you have done all the work yourself.

Asaf Shamsi
CEO & Director, International Operations

PharmAlliance
http://www.pharmalliance.com

Asaf Shamsi
CEO & Director, International Operations
asaf@pharmalliance.com
Mobile: +91 98980 88170
Tel: +91 (79) 4004-9174

_________________________________________

PharmAlliance
http://www.pharmalliance.com

Complete and Comprehensive Co

eswar's picture

Welcome Dear Asaf Shamsi Sir..

Well, First of all happy to interact with CEO of one great organization, Pharmalliance, which I came to know from the reference quoted by Mr. Lucky in his blog. On that day I browsed your site and it looks pretty good providing such a wonderful assistance and guidance in various typical aspects where everyone fails to get it done properl. Your "services" Tab is really appreciable as it deals with issues like ANDA, Preclinical and Clinical aspects support which I like more..
Sir, Actually I thought of contacting you as one of my friends doing his Ph.D. is willing to do his in-vivo work in human volunteers, Will U plz help him by guiding whom he has to contact for getting his work done.
Here he is facing Ethics committee issues...Thats why planning for external source.
Waiting for your reply.
Once again thanks to lucky for making us aware about such a nice site...
eswar :-)

Regardseswar :-)

Would be pleased to help if I can...

Dear Eswar,

Thanks for you message. Please ask your friend to get in touch with me and I will do my best to see if I can help. Our contact information is on our website.

Regards,

Asaf Shamsi
CEO & Director, International Operations

PharmAlliance
http://www.pharmalliance.com

Asaf Shamsi
CEO & Director, International Operations
asaf@pharmalliance.com
Mobile: +91 98980 88170
Tel: +91 (79) 4004-9174

_________________________________________

PharmAlliance
http://www.pharmalliance.com

Complete and Comprehensive Co

Lakshya Untwal  's picture

Re: Quick Access to Regulatory Bodies Across the Globe

Dear Sir,
I regret for the event that has happened. I had no intention of taking the credit for the efforts and time you & your company has spent for this list preparation. I have never said anything like that in this blog or in any of my comments.
I accept that I have kept the format & most of the links as per your site but many have been referred from other sites too. I would also like to say that it was not just from your site alone, I have also referred the sites mentioned under references. I have also visited many of the links to confirm the working of links.
I agree that I should have acknowledged you and your team & also other sources. I tried to put them under the references. But I feel that this was not sufficient. Please let me know what I can do to show my regrets, if you wish I am ready to terminate the blog. If you wish to include some statement I am ready to do that. But please do not say that it is exactly copy-pasted.
I am grateful to you for the statement “While we have absolutely no objections to this information being widely disseminated”, which shows your generosity.
I am sorry for the inconvenience caused to you due o this event. But I am happy that due to this event you have become a part of our group. I will be obliged to if you give me an opportunity to regret for this event.
I hope you will reply back to me.

Dear Lakshya, Thanks for

Dear Lakshya,

Thanks for clearing the matter. Please do not do anything as drastic as terminating your blog! You have a lot of knowledge which would be of tremendous benefit to the community!

With best regards,

Asaf Shamsi
CEO & Director, International Operations

PharmAlliance
http://www.pharmalliance.com

Asaf Shamsi
CEO & Director, International Operations
asaf@pharmalliance.com
Mobile: +91 98980 88170
Tel: +91 (79) 4004-9174

_________________________________________

PharmAlliance
http://www.pharmalliance.com

Complete and Comprehensive Co

Lakshya Untwal  's picture

Re: Dear Lakshya, Thanks for

Dear Sir, I am happy to know that. I felt like getting my spirit right back. I am really thankful to you for becoming a part of our community.
First of all I was really amazed that a CEO has talked to me directly & secondly the way you have interacted has given me great feeling.
I am also interested in knowing job profiles available with your company. I will be happy to have your contact details, are they available on your site or I can contact you thought the contact available here. Please do reply.
Regards.

Mayuresh K.Raut 's picture

GOOD collection of all the

3

GOOD collection of all the important agencies,quiet informative.

Lakshya Untwal  's picture

Re: GOOD collection of all the

Dear Sir, nice to see you back in action. I just tried to represent the information available on various sites, I'll definitely try to give better & more informative blogs.

Dr.Parikshit Bansal 's picture

Good Compilation

5

Dear Lakshya, I was happy to see that you are preparing good database. But as I have already said, you try to add some details, which will provide the basic information about these organizations. I hope from next time you do take care of this.
Dr.Parikshit Bansal

Dr.Parikshit Bansal

Lakshya Untwal  's picture

Re: Good Compilation

Dear Sir, I am really happy to see your comment. Yes I will remember to add details from next blog, even I am trying to compile details of these organizations too. I hope I will be able to accomplish the task soon.

Great...

3

Great lucky... you have put on lots of efforts on putting this blog... great, informative and a quick blog....

Lakshya Untwal  's picture

Re: Great...

Dear Jahnavi, I have just tried to compile a list & was happy to know that you all have liked it.
You too can try n give some such useful links which can be added here.

sure...

Sure, lucky...I would definitely put new links and inform you as soon as I find one...

eswar's picture

Efforts are visible!

4

Dear Lucky,
Your efforts in framing all the useful home pages at one zone are clearly visible in this blog. Very Good job done by you. Keep it up.
Inspired by yur blog, I too come forward to keep some of the links useful to students and others which I am collecting from the long back. Shortly I will come up....
eswar :-)

Regardseswar :-)

Lakshya Untwal  's picture

Re: Efforts are visible!

Dear Eswar, If I am able to inspire even a single person, I'll feel that I have been able to accomplish my job. About framing the useful links it was a dificult job but with the help of many online sources it was made simple.