The 6th “Asia Partnership Conference of Pharmaceutical Associations (APAC)”:
~Accelerating Access To Innovative Medicines through advancing collaborative partnership in Asia~

The 6th “Asia Partnership Conference of Pharmaceutical Associations (APAC)” was held on 5th and 6th April with the mission of “To Expedite the Launch of Innovative Medicines for the Peoples in Asia” under the theme of “Accelerating Access To Innovative Medicines through advancing collaborative partnership in Asia”.

6th APAC Program

Keynote Lecture by Boon M.H.

<Convention Agreement>

Access To Innovative Medicines

・Both Regulators and Industries will work together to create mutually acceptable Site Master File (SMF) template.
・PMDA will share draft SMF template to panelists and lead the discussion in cooperation with Pharmaceutical Inspection Co-operation Scheme (PIC/S) Vice-Chair.
・Regulators will give feedback to PMDA within 3 months.  Industries will give feedback to PMDA within 6 months.

Drug Discovery Alliances

・Advance information sharing, networking and capacity building in drug discovery in Asia by making the best use of established APAC DA-EWG platforms.
・Increase potential of cross-border open innovation in Asia by promoting collaboration initiative using natural compounds and addressing challenges occurred in the collaboration.

Regulations and Approvals

・Continue to promote training for further dissemination of Good Registration Management (GRM) and to provide APAC RA-EWG support for better regulatory environment in Asia.

Other matters

・The Seventh APAC will be held in Tokyo in 2018.

Access To Innovative Medicines Session

At the ATIM (Access To Innovative Medicine) sessions, GMP was on the agenda for the first time. We heard a report on the evaluation process, especially inspections and SMF (Site Master File) / PMF (Plant Master File), from each Asian regulatory authority.  At the panel discussion, we were able to clarify different perspectives of each country, and have fruitful discussions for improving the efficiency of our evaluation process.

Current Status of Desk-top GMP inspection in Japan

GMP compliance assessment process and future possibility in Korean

Assessment Process of GMP Compliance in Taiwan: Current status & Future possibility

Current GMP Compliance Process and Future Possibility in Thailand

GMP compliance assessment in Indonesia

Potential Areas for Improvement of GMP Compliance Assessment: Suggestion from JPMA

Drug Discovery Alliance Session

This year, we focused on the use of natural resources as a specific area of drug discovery cooperation in Asia.  We have reconfirmed the attractiveness of drug discovery using natural compounds, taking advantage of the abundant natural resources and geographical merits of Asia, and the development of the novel screening technology.

Introduction to the DA Session: Dawning Era in Drug Discovery with Natural Resources in Asia

Keynote Lecture: Continued Efforts to Discover New Drugs using Natural Resources

Drug discovery using natural compounds in Thailand: An Update

Drug discovery using natural compounds in Taiwan

Application of natural resources to drug discovery in Eisai

Activities of Pillar 5 (Natural Product Drug Discovery Network)

Regulation & Approval Session

We discussed how to implement an efficient and high quality registration process.  The GSubP(Good Submission Practice) proposal by EWG and the GRevP (Good Review Practice) by the regulatory authorities have counterbalanced each other, and resulted in GRM (Good Registration Management).  It is the great achievement that we have reached the stage where we can discuss its implementation in actual application.

Introduction of RA-EWG Session

GRM Pilot CoE workshop – Reviewers Training

Promotion of Good Submission Practice in Asia

Forward-looking approaches & its Experiences of PMDA’s ACT (Asia Training Center)