The Quality Overall Summary (QOS) is an element of a drug marketing application that provides a substantially condensed summary of the quality-related data provided in the submission. Regulators can use the QOS to more effectively assess applications and more rapidly comprehend the quality information in the context of patient risk, including the proposed control strategy and any other planned steps to mitigate that risk. Patients benefit from the greater assessment efficiency by having improved access to drugs that are designed and manufactured to consistently and safely fulfill claims in the label.
News & Trends
Procurar
Recentes
- ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) Annex 2 .Final version
- Team-NB Position Paper: MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
- 2025 AI Observatory report
- The EU new standard template covering recruitment and informed consent procedures.
- EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
- MEDTECH EUROPE : An Improved Regulatory Framework: What Do Europe’s Diagnostics Need?
- European Data Protection Board public consultation on the draft Guidelines on the processing of personal data for scientific research
- Statistical Approaches to Establishing Bioequivalence