Core Data Sheet is an unofficial working document prepared by marketing authorization holders typically containing material relating to safety, indications, dosing, pharmacology, and other information

A finite set of standardized terms.

In the EU, other countries that review the Application during or after the Reference Member State review.

[FDA] A written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an application or abbreviated

A medicine’s regulatory authority in the European Union. Source: EMA Glossary

The Common Technical Document (CTD) is a format for marketing applications submitted to ICH participating regions, controlling the organization of information in an application.

“The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines. The CHMP plays a vital

“Activities to be performed by or on behalf of a Party or its Affiliates as a condition or in connection with receipt of Regulatory Approval

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and

See Manufacturing Supplement. [FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the

“In the EU, individual member states review and approve individual applications to run clinical trials within that country. One application is submitted for each clinical

The Clinical Data Interchange Standards Consortium is a standards developing organization dealing with medical research data linked with healthcare, to “enable information system interoperability to

That part of pharmaceutical development that deals with the nature of the drug substance and drug product, the manner in which both are made, and

Chemical Abstracts Service (CAS) Number: A unique accession number assigned by the Chemical Abstracts Service, a division of the American Chemical Society. Other than being

A checksum is a sequence of numbers and letters used to check data for errors. If the checksum of an original file is known, an

Certificate of Suitability to the monographs of the European Pharmacopoeia. A certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with

Another term for Centralised Procedure (CP). “An EU Procedure type in which the EMA (European Medicines Agency) reviews and approves the application on behalf of

“An EU Procedure type in which the EMA (European Medicines Agency) reviews and approves the application on behalf of all European Union countries.Certain drugs, such

The Center for Drugs Evaluation and Research (CDER) is the division of FDA that is responsible for the licensing and regulation of pharmaceuticals (with the

FDA Division that assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Source:

The Center for Biologics Evaluation and Research (CBER) is the division of FDA that is responsible for the licensing and regulation of biologic drug products.

Authorisation in the European Economic Area (EEA) for the marketing and sale of devices, and specifically within Life Sciences, Medical Devices.