international activities of pmda encouraging new ... · pdf fileapplication for marketing...

16:15-16:35, October 13th, 2010The 10th Kitasato University – Harvard School of Public Health Symposiumat Nikkei Hall, 1-3-7 Otemachi, Chiyoda-ku, Tokyo

Masaaki TSUKANODivision of Regulatory Cooperation, Office of International Programs,

Pharmaceuticals and Medical Devices Agency

International Activities of PMDA encouraging

new pharmaceuticals development in Asia

・This set of slides partly contains speaker’s personal view and those are not necessarily formal view of the Pharmaceuticals and Medical Devices Agency.

・Because some of the slides sacrifice preciseness in order to pursue quick understanding, please consult original source documents for precise details.

・These PowerPoint slides are the intellectual property of the Pharmaceuticals and Medical Devices Agency and are protected under the copyright laws of Japan and other countries.

Copyright ©2010 Pharmaceuticals and Medical Devices Agency

We can see the following phrases; We will be the bridge between the patients

and their wishes for faster access to safer and more effective drugs and medical devices.

We play an active role within the international community by promotinginternational harmonization.


We can see the following concepts; Strengthening of cooperation and building of

collaborative relations with the United States (US), the European Union (EU), Asian countries, and relevant international organizations

Promotion of International Clinical Trials (ICT) by giving advice on ICT, based on guidance for designing CT


Office of International Programs (OIP)in April 2009

with the mission of future directions to strengthen cooperation withthe EU, the US and Asian countries, and play a vital role in Global arena


Administration

Adverse health effect Relief

Review (Pharmaceuticals)

Post-market vigilanceGMP, QMS inspection


GCP inspection

Review (Medical Devices)

OIP

Based on the recommendation of the Council for Science and Technology Policy dated December 25, 2006, PMDA planned;

236 increase in 3 years from FY2007


Approved personnel Time clock (goal)

G+O+Q As of Apr. 1st

New PharmaceuticalsUnit in Months

PM

FY’05 6,100 291 12 (reg)(SRI) 70%Twd *1 (PRI) at end‘08

FY’06 5,469 319 12 (reg)(SRI) 70%Twd *1 (PRI) at end‘08

FY’07 6,843 341 12 (reg)(SRI) 70%Twd *1 (PRI) at end’08

FY’08 6,141 426 12 (reg)(SRI) 80%6 (reg) (PRI) 50% (*1)

CS

FY’09 7,663 521 19 (tot) (SRI)(Med)11 (tot) (PRI) (Med)

FY’10 605 16 (tot) (SRI)(Med)10 (tot) (PRI) (Med)

FD

FY’13 751(Mar. ’14)

12 (tot)(SRI)(Med)9 (tot)(PRI)(Med)


NP/SRI 2006 2007 2008 2009Review time (aplct)

6.9 7.9 7.4 6.7

Review time (reg)

12.8 12.9 11.3 10.5

Review time (tot)

20.3 20.7 22 19.2

No.approved 29 53 53 92


Review time (aplct)Review time (reg)Review time (tot)

0

5

10

15

20

25

2006 2007 2008 2009Copyright ©2010 Pharmaceuticals and Medical Devices Agency

Mos FY2006 FY2007 FY2008 FY2009RP(aplct) 6 6.5 6.8 6.4RP(reg) 6.4 4.9 7.3 3.6RP(tot) 13.7 12.3 15.4 11.9No.approval

20 20 24 15


RP(aplct)RP(reg)

RP(tot)0

5

10

15

20

FY2006FY2007

FY2008FY2009


New system started from FY2009 as pilot project which allows applicants to consult reviewers on non-clinical and clinical data before application for marketing approval.


No. of Consultation & IND registration on GCT

Give scientific advice based on “Basic Principles on Global Clinical Trials”.

15

Trend of No. of consultation on GCT※

Trend of IND registration on GCT

※consultation on compliance with data reliability standard, consultation on pre-application assessment and consultation on pharmacogenomics / biomarker are not included.

No. Percentage of consultation on GCT（％）

First IND registration on GCT (a)

Percentage of GCT IND registration in the total (a+b)

Second and further IND registration on GCT (b)

No.No. (％） (％）

FY2005 FY2006 FY2007 FY2008 FY2009

FY2007 FY2008 FY2009

Building of collaborative relations

US/FDA

Other Asia-pacific economiesCanada, Australia etc.

International Organizations：WHO,OECD

PMDA /MHLW

EC/EMA

Asia

ICHBilateral meeting

Bilateral meeting PDG


RHSCRHSC

ICH: International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (1990~) 20th

anniversary3 regions 6 parties

more than 50 guidelines

PDG: Pharmacopoeial Discussion Group (1989~)harmonized 40 monographs on additives and 27 test

methods

RHSC under APEC LSIF: Regulatory Harmonization Steering Committee (2008~)Asia-pacific regions 21 economies


1) Maximize benefit

2) Minimize risk


To avoid unnecessary duplication of study on quality, safety and efficacy of pharmaceuticals, harmonize technical requirements for registration of pharmaceuticals, that allows industry to submit the same data to regulatory authorities, which propels R&D, shorten period before approval for marketing authorization, enables patients to access safe and efficacious pharmaceuticals faster.


’09 Jan. MOU (China SFDA & Japan MHLW)

’10 Jul. 1st High level Annual Meeting



‘07 Apr. Seoul 1st Tripartite Health Ministers (HMs) Mtg. ‘08 Apr. Tokyo 1st Tripartite Director-Generals (DGs) Mtg.

1st East Asian Regulatory SymposiumNov. Beijing 2nd HM

’09 Aug. Tokyo 1st Working Group (WG)Nov. Tokyo 3rd HMDec. Beijing 2nd WG

2nd DGThe Drug Clinical Trial Symposium

- Japan leads project of the research on ethnic factor

- Korea leads project on information exchange in the field of clinical trials


Mon. 13th Sep. 2010 at Seoul Korea WG Mtg.(13th), DG Mtg.(13th) and DG Symposium (14th)

combined with AHC MRCT Seoul Workshop (13th-15th) Outcome:

1) WG ToR modified and adopted & agreed on its publication2) Establishment of RG was agreed as to research on ethnic factors3) Comparison will be made on clinical trial regulation in Korea, China and Japan4) Next DG Mtg. will be held in Japan in Autumn 2011


PMDA supports the Roadmap to promote Multi Regional Clinical Trial (MRCT) which was proposed by MHLW in the RegulatoryHarmonization Steering Committee (RHSC) of the Life Science Innovation Forum (LSIF) of the Asia-Pacific Economic Cooperation (APEC)


If it is the case with diseases which are prevalent in Asia such as Stomach Cancer and Hepatocellular Carcinoma;

1. Can enroll patients easily when compared with other regions

2. Latest diagnostic & therapeutic technique are available in Japan



Theme: Follow-on biologics (Biosimilar) Tuesday, 17 February, 2009 / 10:00-16:50 at Yakult Hall

Speakers invited from: EMEA, NIHS, JPMA, FDA, PhRMA, EBE-EFPIA, EGA, WHO, Health Canada

Theme: The clinical evaluation of the cell/tissue-based productsFriday, 9 October, 2009 / 13:30-17:30 at Nadao Hall

Speakers invited from: Paul-Ehrlich-Institut, PEI, Japan Tissue Engineering Co.,LTD., Yokohama City University Medical Center, Institution of biomedical research and innovation

Thursday, August 26, 2010 / 13:30-17:35 at Nadao Hall Theme: Quality and non-clinical evaluation of cell/tissue-

based products Session I FDA's perspective on quality and non-clinical

evaluation of cell/tissue-based products/ EMA, French and German perspective on quality and non-clinical evaluation of cell/tissue-based products

Session II PMDA's perspective on quality and non-clinical evaluation of cell/tissue-based products/ Researcher's perspective on quality and non-clinical evaluation of cell/tissue-based products

Panel Discussions


Nov. 29 to Dec. 3, 2010 at PMDA For new drugs/biologics reviewers in regulatory

authorities This time is mainly for pharmaceuticals/biologics In the English language No registration fee required Participants must shoulder their own travel

expense, accommodation & other necessary expense for participation.


Japanese Drug Regulation Japanese Pharmacopoeia, PDG and ICH Q4B GCP/ GLP GMP Relief Services for ADR sufferers Review of New Drugs & Biologics Post-marketing Safety Measures Pharmacology Pharmacokinetics Toxicology Clinical Studies Biostatistics Pharmacogenomics Over the Counter / Generic Drugs Review of Medical Devices


Accept three from KFDA and one from SFDA in 2010.


SpeedQualityCostLatest science & technology


which are based on the new Five-Year Plan for National Clinical Trial Vitalization to build and strengthen capacity and infrastructure relating to medical institutions that conduct clinical trials, PMDA is contributing through improvement in review performance and mechanism, and international activities, to promote development of pharmaceuticals in Asia.


accelerate review speed

(1) of PMDA itself by increasing number of reviewers

(2) of Asian countries (i) by training Asian regulatory authorities at

PMDA seminar etc.,(ii) by providing guidelines on PMDA website,(iii) by sharing experience of best practice in

activity on GCP of ICH Regulators Forum etc.Copyright ©2010 Pharmaceuticals and Medical Devices Agency

improve quality

(1) directly through guidance by PMDA inspectors at the time of GCP on site inspection

(2) indirectly through guidance of medical institutions by each regulatory authority who learned from PMDA


lower development cost(1) for application in Japan

(i) by accepting foreign clinical data by PMDA based on ICH E5 guidelines

(ii) by shortening review time by PMDA → speed (2) for application in Asian countries

(i) by shortening review time by Asian regulatory authorities who learned from PMDA → speed

(ii) by improving efficiency of clinical trial in Asia through direct and/or indirect guidance


http://www.pmda.go.jp/english/index.html

http://www.pmda.go.jp/operations/notice/2007/file/0928010-e.pdf

http://www.pmda.go.jp/english/upcoming/201008_seminar.html#4


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