Since we joined PIC/S, which is pharmaceutical inspection co-operation scheme consisting of Europe and the United States and the other major countries, at the same time as Korea in July 2014, PMDA's Office of Manufacturing/Quality and Compliance has been conducting GMP inspections in line with international standards.
In the light of present situation surrounding Japan, with the aim of contributing to the international harmonization of the GMP ministerial ordinance and further strengthening the quality assurance system at the manufacturers which medicinal products distributing in Japan, we began to consider revision of the GMP ministerial ordinance incorporating with the latest international standards since FY 2016 and summarized the final draft.
This presentation will cover GMP inspection experience of PMDA including introduction of examples of critical/major observations we found and future perspective of GMP in Japan including introduction of proposed revision of the GMP ministerial ordinance.
EU rules on nutrition and health claims have been established by Regulation 1924/2006 which started to apply in 2007.
EAS Strategies will provide a snapshot of the EU regulatory framework surrounding claims on foods, in the product label or in its advertising.
This session will highlight the key regulatory features, the types of claims, the authorisation procedures and the status quo of what is authorised and prohibited in the EU.
EAS Strategies will guide participants through the do's and don'ts when making a new claim for a food to be marketed in the EU.
With practical cases, this session aims to give a checklist and provide clarity on how to communicate about the properties of foods in the EU, to consumers directly but also to businesses or health care professionals.
The ICH E6 GCP was revised in 20 years in November, 2016 and there has been E6 addendum provided. In this seminar, we are going to talk about major changes following the revision of ICH E6, and the guidelines issued by MFDS last year focusing on safety evaluation and reporting of clinical trials, which has attracted keen attention.
Pharmaceuticals is one of the main industries which requires security standards of transportation. Based on TAPA (The Transport Asset Protection Association) standards, we will look through what we can do to secure your supply chain for pharmaceutical safety. Brink's case study for shipping validation of temperature controlled vehicle would help to complement the integrity and safety of your supply chain.
The WHO Prequalification Team provides advice to UN agencies and international medicine procurers on the quality, safety and efficacy of purchased medicines. In most cases, eligibility for procurement requires the medicine to be either approved by a Stringent Regulatory agency or prequalified by the WHO Prequalification Team.
This presentation will provide an introduction to the medicine and API prequalification programme including: who may apply, what are the requirements and procedures. The possibility for arranging technical assistance to potential manufacturers who wish to participate will be outlined.
Finally, the presentation will also introduce the WHO collaborative procedure. This is a procedure introduced to significantly reduce national registration times for prequalified products, allowing sales of the medicine to the local market quickly. The procedure requests a decision from the national medicines authority within 90 days. Nearly 30 countries are now participating in this scheme.
Speaker: Matsutaro Fuji
Speaker: Matsutaro Fuji