Regulatory Terms Starting With M

8 terms in the M index.

• Market Exclusivity (Exclusivity)

  Market Exclusivity is a statutory bar FDA enforces after approving a drug or biologic, blocking the submission or approval of competing generic, 505(b)(2), and biosimilar applications for a fixed period independent of any patent.

• Marketing Authorization Application (MAA)

  Marketing Authorization Application (MAA) is the dossier a sponsor files to place a medicine on the European Union market. Unlike a US NDA, it is granted by the European Commission on EMA's scientific recommendation.

• Master Protocol (Master Protocol)

  Master Protocol is a single overarching clinical trial protocol under which multiple sub-studies run simultaneously, evaluating several investigational products, several populations, or both within one shared infrastructure, control group, and statistical framework.

• MDR (Medical Device Reporting)

  MDR (Medical Device Reporting) is the FDA post-market surveillance regime requiring manufacturers, importers, and device user facilities to report device-related deaths, serious injuries, and specified malfunctions to FDA on fixed deadlines.

• Medical Dictionary for Regulatory Activities (MedDRA)

  Medical Dictionary for Regulatory Activities (MedDRA) is the standardized medical terminology ICH regions use to code adverse events, indications, and medical history in safety reports, structured as a five-level hierarchy from Lowest Level Term up to System Organ Class.

• MedWatch (MedWatch)

  MedWatch is FDA's safety reporting program and form set for human medical products, covering both voluntary reports from clinicians and patients and the mandatory postmarket reports sponsors and manufacturers must file under 21 CFR.

• MHRA (Medicines and Healthcare products Regulatory Agency)

  MHRA is the United Kingdom's regulator of medicines, medical devices, and blood components for transfusion, granting UK authorisations through its own assessment or by recognising a named reference regulator, not through the EU centralised procedure.

• Minimum Anticipated Biological Effect Level (MABEL)

  Minimum Anticipated Biological Effect Level (MABEL) is the human exposure predicted to produce the lowest biologically observable effect, calculated from pharmacology rather than toxicology, and used by EMA as one of three permitted anchors for a first-in-human starting dose.