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F Iq, PHARMACEUTICAL INSPECTIoN CoNVENTIoN1,T I * PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME

PIC/S Secretariat14, Rue du RoverayCH.12O7 GENEVATel: +41 227389215Telefax: +41 227389217E-mail: daniel.brutner@oicscheme.orqWeb site: hthl://!,.vldw. 0icsaheme.org

Dear Dr Boonchai,

ACCBSSION OF THAI FDA TO THE PIC SCHEME

I have the honour of confirming to you that on 4-5 July 2016, the PIC/S Committee,convening in Manchester (United Kingdom), accepted the PIC/S membershipapplication made by Thailand's Food and Drug Administration (Thai FDA).

The PIC/S membership of ThaiFDA will become effective as lrom I August 2016.

I attach the document "Pharmaceutical Inspection Co-operation Scheme" GfC/S 1/95(Rev. 5)), whose provisions should be applied by Thai FDA as from its accession.

In line with the Accession Guidelines (PS/W 1412011 (Rev. 1)) I kindly invite you toreturn the attached acceptance letter on your letterhead to the PIC/S Secretariat at yourearliest convenience.

In my capacity as Secretary to the PIC/S Committee, I am very pleased to welcome ThaiFDA as PIC/S' 49th Participating Authority. I would also like to congratulate Thai FDAfor having successfully completed the application process and thank you as well as

Ms. Prapassorn (Tim) Thanaphollert and all inspectors at Thai FDA for your combinedeffotts to comply with the Scheme's requirements.

Yours sincerely,

Daniel Brunner

Dr Boonchai SomboonsookFood and Drug Administration (Thai FDA)Ministry of Public HealthTiwanon RdTH . NONTHABURI l1OOO

THAILAND

Encl.

PS1L 6t201614 July 2016

© PIC/S 2016

www.picscheme.org

Leading the international development, implementation and maintenance of

harmonised GMP standards and quality systems of inspectorates in the field of

medicinal products

July 2016

Press release: PIC/S Meetings in Manchester (United Kingdom)

From 4 to 8 July 2016, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) hosted the following events in Manchester (UK): PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar.

PIC/S COMMITTEE MEETING

PIC/S Chairman, Mr Paul Hargreaves (UK / MHRA)

The PIC/S Committee met on 4-5 July 2016, under the chairmanship of Mr Paul Hargreaves (United Kingdom’s Medicines and Healthcare products Regulatory Agency / MHRA). The meeting was attended by 41 out of 48 PIC/S Participating Authorities (PA) as well as by a number of Applicants, Pre-Applicants, Associated Partners and Guests.

THAI FDA JOINS PIC/S

The PIC/S Committee invited Thailand’s Food and Drug Administration (Thai FDA) to join the Scheme from 1 August 2016. Thai FDA will become PIC/S’ 49th Participating Authority. Thai FDA applied for a second time for membership in March 2015. A paper assessment was conducted in view of its accession to PIC/S, followed by an on-site visit in March 2016.

© PIC/S 2016

The PIC/S assessment of Thai FDA covered both traditional and modern medicines. The Audit team recommended to the Committee to accept the PIC/S membership application of Thai FDA. The Thai FDA Delegation in Manchester was led by the Secretary General of Thai FDA, Dr Boonchai Somboonsook.

From left to right: Dr Suchart Chongprasert (Thai FDA), Dr Boonchai Somboonsook, Secretary General of Thai FDA, Mr Jacques Morénas, Rapporteur for the application of Thai FDA (France / ANSM), Ms Prapassorn Thanaphollert (Thai FDA), Mr Daniel Brunner, Secretary of PIC/S.

PIC/S INSPECTORATES’ ACADEMY (PIA) IS NOW LIVE

The PIC/S Inspectorates’ Academy (PIA) is now up and running. The PIA is a PIC/S initiative to set up a web-based educational centre under the PIC/S umbrella which aims at harmonising and standardising GMP training at an international level through a certified qualification system. PIA delivers not only general or advanced training but also serves as a platform for discussion and sharing among regulators. It offers a single point of access to all PIC/S training activities and is being implemented in various stages. The PIC/S Deputy Chairman and visionary of the PIA, Mr Boon Meow Hoe (Singapore / HSA), also serving as Chair of the PIA Project Management Steering Committee (PMSC), announced the completion of stage 1 of the PIA, i.e. a dedicated web-based platform internal to PIC/S incorporating all PIC/S training materials, which will be accessible to all PIC/S Inspectorates, bringing together today 1789 PIC/S inspectors. The site is presently live at https://www.picscheme.org/en/pia-home. Login is required for the PIC/S inspector-only area. With the completion of stage 1, stage 2 of the PIA will now start and focus on developing modules (e-learning) responding to specific training needs, to be identified, including possible co-operation with external stakeholders, as well as the development of PIC/S training recognition and certificates. The PIA website is a sub-website of the new PIC/S website which is available at https://www.picscheme.org