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Glossary
With plenty of acronyms, procedures or references, the regulatory and market access
environments are sometimes perceived as daunting. Deciphering the language is the
start to finding one’s path.
A (3) | C (9) | D (2) | E (8) | F (4) | I (8) | M (3) | N (4) | O (1) | P (12) | Q (2) | R (1) | S (6) | T (1) | V (1)

Latest Glossary Articles


Marketing Authorization Application (MAA)

The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that therapeutic benefits outweigh risks.

Pharmaceutical Establishment License (PEL)

Whilst marketing approval is granted for a given product, the company applying for marketing license may also be subject to certification by regulatory authorities.

Clinical Trial Application (CTA)

The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.

Paediatric Investigation Plan (PIP)

A number of regulatory provisions, structures and procedures aim at increasing the development of medicines for use in children.

Orphan Drug Designation (ODD)

Most health authorities promote the development of orphan drugs, by offering a series of incentives to companies developing treatments or diagnostics for rare diseases.

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