The EMA has issued these guidelines for the conduct of pharmacovigilance in the EU for human medical products.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results

The Gulf Co-operation Council (GCC) includes: State of United Arab Emirates, Kingdom of Bahrain, State of Kuwait, Sultanate of Oman, State of Qatar, Kingdom of

A non-binding document issued by an agency representing their current thinking on best practices.

A grouped submission is a single submission unit that is applied to more than one submission. Grouped submissions are the only business case for sending

A Global Trade Item Number (GTIN) is a unique and internationally recognized identifier for a product.

A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration,