Regulatory collaboration

ASEAN Regional Training Centre for QCL and WHO Collaborating Centre in the Regulatory Control of Pharmaceuticals. 

The adoption of CADDY within the EU has provided a sound basis for the transfer of regulatory dossiers between industry and regulators. CADDY has been developed from inception to a workable system in 5 years and represents a significant collaborative effort between industry and the regulators drawn from both North America and Europe. This initial achievement has resulted in substantial reductions in compiling, transporting, and handling costs for EU dossiers and has provided a basis for rapid... 

For submissions involving medical devices and/or drugs that are not clearly addressed in this agreement, sponsors are referred to the product jurisdiction regulations (21 CFR Part 3). These regulations have been promulgated to facilitate the determination of regulatory jurisdiction but do not exclude the possibility for a collaborative review between the centers. 

The development process starts with a thorough planning step in which a development plan is generated by the collaboration of all stakeholders, such as quality assurance (QA), QC sourcing sites, stability, development, and regulatory functions. Planning should also include information gathering to obtain ... 

It would be wrong to give the impression that the PAT initiative is confined to the FDA. The FDA has increased its collaboration with international health and regulatory partners, including the International Conference on Harmonisation for the Technical Requirements for Registration of Pharmaceuticals (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Veterinary Medicinal Products (VICH). 

Reports and guidelines from drug regulatory authorities, health authorities or other independent institutions, like the Cochrane Collaboration, are valuable in many aspects. Drug regulatory authorities have, in the process of drug... 

More active collaboration between pharmacovigilance centres (close to practitioners and patients), regulatory authorities, and the pharmaceutical industry and other players. 

---