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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


Scientific Advice (SA)

Scientific advice is the provision of advice to a company by the European Medicines Agency on the appropriate tests and studies required in the development of a medicine or on the quality of a medi

New Chemical Entity (NCE)

A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and approved drug products.

New Drug Application (NDA)

A NDA is the final step formally taken by a drug sponsor, wherein it applies to the Food and Drug Administration (FDA) for the approval required to market a new drug in the U.S.

Target product profile (TPP)

A TPP is a format for a summary of a drug development program described in terms of labeling concepts.

Protocol assistance (PA)

Protocol assistance is the special form of scientific advice available for companies developing designated orphan medicines for rare diseases.

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