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Regulation Sources


EMEA - The European Agency for the Evalution of Medicinal Products
The Agency is in charge of coordinating the scientific resources of Member States with a view to evaluating and supervising medicinal products for both human and veterinary use. The site contains a comprehensive collection of notes for guidance, application procedures, fees etc., in the field of human and veterinary medicines.

FDA - CBER Guidances, Guidelines, Points to Consider
The Center for Biologics Evaluation and Research (CBER) regulates biological products. The regulatory documents issued by CBER cover the following topics: allergenics, blood, devices, FDA Modernization Act, gene therapy, ICH, investigation of new drug, tissue and vaccines.

FDA - CBER Reading Room (EFOIA)
The CBER Reading Room provides access to all the documents posted on the CBER website. These documents are frequently requested by the public through the Freedom of Information Act.

FDA - CBER Recalls - Withdrawals
List of recalls and withdrawals. The list contains the product name, the company name and the effective date of recall or withdrawal.

FDA - CDER Center for Drug Evaluation and Research Guidance Documents
Search page of FDA CBER and CDER guidance publications.

FDA - CDER Regulatory Information
CDER evaluates all new drugs before they are sold, and serves as a consumer watchdog for more than 10,000 drugs on the market ensuring they continue to meet the highest standards. This page lists the CDER regulatory & scientific guidance publications.

FDA - CDRH Center for Devices and Radiological Health Guidance Documents & Reports
FDA's Center for Devices and Radiological Health is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. Good Guidance Practice (GGP) documents are documents prepared for CDRH staff, regulated industries, and the public that relate to: the processing, content, and evaluation of regulatory submissions; the design, production, manufacturing, and testing of regulated products; inspection and enforcement procedures.

FDA - ORA Office of Regulatory Affairs
The Office of Regulatory Affairs (ORA) is the lead office for all Field activities of the Food and Drug Administration. This site is a list of all ORA documents and guidance publications.

Health Canada Acts and Regulations
These pages are the Departmental consolidation of the Food and Drugs Act and of the Food and Drug Regulations issued by the Department of Health Canada.

Health Canada Guidelines
Guidelines issued by Health Canada on a well organized page.

ICH - (International Conference of Harmonisation) Topics and Guidelines
ICH is a joint initiative involving both regulators and industry as equal partners in scientific and technical discussions on the testing procedures required to ensure and assess the safety, quality and efficacy of medicines. The ICH Topics are divided into four major categories (quality, safety, efficacy and multidisciplinary). The guidelines derived from the topics are in pdf format.

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21 CFR Part 11 Issues
Various aspects of electronic records and electronic signatures
Forum Database
Almost 100,000 searchable messages from 16 working newsgroups. Updated regularly.
Warning Letters Knowledge Base
An extremely versatile database that will assist familiarization with the regulatory requirements
Competency Trainings & Exams
Multimedia enriched learning materials, exercises and exams.
On-line Trainings & Exams
Web-based learning materials, exercises and exams

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