Fariel: Regulatory Compliance

Fariel™ Consulting, LLC Regulatory Compliance

Fariel™ consultants are versed art of global regulatory compliance. Here you will find useful links on a few regulatory agencies and their respective compliance requirements.

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Miscellaneous Non-Governmental Links
	21CFRPart11.com
	This site contains a number of interesting links and documents, many of which fall outside of the scope of 21 CFR Part 11 related issues and some of which pertain to non-US regulatory requirements. If you are interested in being kept up-to-date on regulatory changes and updates concerning the FDA, this site also allows you to subscribe to their mailing list, free of charge.
United States
	Code or Federal Registers Title 21 (21 CFR)
	This is the United States Federal Government's on-line access to the Code of Federal Registers, Title 21, Chapter I "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES". Part 11: "ELECTRONIC RECORDS; ELECTRONIC SIGNATURES" is also known as "21 CFR Part 11", and is in large part responsible for keeping many in our field employed.
	Food and Drug Administration (FDA)
	This is the web site for the regulatory agency responsible for pharmaceutical or medical device enforcement in the United States. Some of the most pertinent links on their site relating to the electronic data collection, retention and submission requirements are listed below.
	FDA - Compliance References
	This is a page with links to the references used by FDA personnel. Of particular interest for all those who are involved in information technology management are the Application Integrity Policy, the Bioresearch Monitoring Program, the Electronic Records; Electronic Signatures, 21 CFR Part 11, the Compliance Program Guidance Manual (CPGM), and the Compliance Policy Guides (CPG) documents.
	FDA - Revisions and Update List
	The FDA posts all revisions and updates to the documents that it posts on-line here. Check it often.
	FDA - Guidances On Electronic Records
	A very important page for those who deal with electronic records. The FDA places much of the material that you need to know here, but be careful, you still need to meet all of the other requirements set forth for all practices, including but not limited to those mandated for paper filing, unless otherwise specified.
European Union
	European Medicines Agency (EMEA)
	This is the main regulatory agency for the member countries in the European Union. Unfortunately, as of writing of this document, not all of the member countries accept unaltered or unsupplemented the filings submitted to the EMEA, so some direct company-to-country supplemental communication is occasionally needed. We will try to update the EU section with a more thorough list of discrepancies and issues soon.
Japan
	Ministry of Health, Labour & Welfare (MHLW)
	This is the ministry responsible for regulatory oversight in Japan. The Pharmaceutical and Medical Safety Bureau is the bureau specifically responsible for regulatory oversight of drugs and medical devices. Unfortunately, as the writing of this document, the site lacks a fair amount of information and, although it's a good starting point, you will need to do much more research
	Japan Pharmaceutical Manufacturers Association (JPMA)
	This is a useful site and organization. Here you will find not only interesting information, but some well organized documents on such topics as the "Pharmaceutical Administration and Regulations in Japan", for example.