I. , L. Meetings, . Ppwg, . La, and .. De-consultation, 36 A. L'organisation et le déroulement, 36 B. La procédure opérationnelle et les différentes étapes, p.37

I. Les and M. De, 47 A. Le système de surveillance post?AMM (PMA), La Bio ? équivalence et la Bio ? disponibilité, p.48

B. ???, 123 1. Dénomination et forme pharmaceutique du médicament : Name and pharmaceutical form of the medicinal product

. Ce-médicament-fait, objet d'une autorisation de mise sur le marché dans le pays exportateur ? Is this medicinal product the subject of a marketing authorisation in the exporting country? a) oui / non yes / no b) demande en cours : oui / non (entourez la réponse adéquate et, le cas échéant, complétez- la). application pending: yes / no (circle the appropriate response and complete it

.. .. ?????-??, autorisation de mise sur le marché et date de délivrance : Marketing authorisation number and date of issue, 2A.1 Numéro de l

T. They, . The, . Runs, . The, and . Market, HSA lors d'une demande d'AMM à Singapour 4) BATCH ANALYSIS (COA for Finished Product)'P5.4' Ref: COA's submitted from Batch No. 4202224 & 4202212. Concerns: There is no indication of the batch size in the COA's that was submitted. Hence, the DCA will not be able to verify whether are these from the actual batch runs (B/N: 4202224 & 4202212) or just trial batches, Annexe Actions: AGUETTANT TO PROVIDE A SIGNED DECLARATION/CONFIRMATION LETTER ON THE BATCH SIZE OF BATCH, vol.4, pp.4202224-4202212

S. Data-'p8, Please refer to file 32p8 (Page 141?144) of your diskette under the heading 'STABILITY'. Concerns: Dossier only describes about the stability studies/data that are conducted on the finished products. The DCA would also want to see the stability data/studies that are conducted AFTER DILUTION, DATA ON FINISHED PRODUCT AND AFTER DILUTION AS WELL

A. Leaders, The ASEAN Declaration (Bangkok Declaration) 1967, 2010.

A. Leaders, Treaty of Amity and Cooperation in Southeast Asia, 1976.

A. Leaders, Singapore Declaration of 1992, 2010.

A. Collins, Security and Southeast Asia: Domestic, Regional, and Global Issues, 2003.

A. Leaders, ASEAN Vision 2020 " ; signed at 2nd Informal ASEAN Summit in 1997, 2010.

A. Leaders, Declaration of ASEAN Concorde II, 2003.

A. Leaders, Cebu Declaration on the Acceleration of the Establishment of an ASEAN Community by 2015, 2010.

A. Secretariat, ASEAN Political ? Security Community Blueprint, 2009.

A. Secretariat, ASEAN Socio-Cultural Community Blueprint, 2009.

A. Secretariat, The Motto, 2010.

A. Secretariat, The Emblem, 2010.

A. Secretariat, The Anthem, 2010.

A. Leaders, Annex 1 " Asean sectoral ministerial bodies, 2007.

A. Secretariat, The Chair ASEAN's regional Integration Challenge: The ASEAN Process, -93, b) Amitav, A (2001) Constructing a Security Community in Southeast Asia: ASEAN and the Problem of Regional Order, pp.47-68, 2004.

A. Secretariat, Summit, 2010.

A. The and . Secretariat, The ASEAN Secretariat: Basic mandate, Functions and Composition, 2010.

A. Leaders, Cebu Declaration on the Blueprint of the ASEAN Charter, 2010.

A. Leaders, Declaration of the ASEAN Concorde II, 2010.

A. Secretariat, AFTA, 2010.

A. Leaders, ASEAN Framework Agreement for the Integration of Priority Sectors, 2010.

A. Secretariat, ACCSQ Structure and scope of activities, 2010.

. Zahn, Developments from ASEAN's ACCSQ Pharmaceutical Product Working Group, Regulatory Affairs Journal, pp.12-2001, 2001.

Y. Javroongrit, Regional update ASEAN PPWG The ICH-Global Cooperation Group Meeting, 2007.

A. Secretariat, ACTD&ACTR formats and guidelines, 2010.

. Eu-commission, Enterprise Directorate-General (page consultée le 15 septembre 2010) Notice to Applicants

. Eu-commission, Enterprise Directorate-General (page consultée le 15 septembre 2010)

I. Q2b, Guideline on Validation of Analytical Procedures: Methodology, 1996.

I. Q5b, Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products, 1995.

I. Q5c, Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products, 1995.

I. Q5d, Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products, 1997.

I. Q6a, Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, 1999.

I. Q6b, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, 1999.

I. S1a, Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals; 1995 ICH S1B: Testing for Carcinogenicity of Pharmaceuticals, 1997.

I. S2a, Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 1995.

I. S2b, Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 1997.

I. S3a, Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies, 1994.

I. S3b, Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies, 1994.

I. S4 and S. , Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing), 1998.

I. S6, Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; 1997 ICH S7A: Safety Pharmacology Studies for Human Pharmaceuticals, 2000.

I. E1, The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions, 1994.

I. E2a, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, 1994.

I. E2c, Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, 1996.

I. E4, Dose-Response Information to Support Drug Registration, 1994.

I. E7, Studies in Support of Special Populations: Geriatrics, 1993.

I. E10, Choice of Control Group and Related Issues in Clinical Trials, 2000.

I. E11, Clinical Investigation of Medicinal Products in the Paediatric Population

I. E12a, Principles for Clinical Evaluation of New Antihypertensive Drugs, 2000.

A. Medical-enewsletter, ASEAN signs MRA for GMP http, 2010.

A. Secretariat, Report of the 13 th meeting of the ACCSQ ? PPWG, 2007.

A. Secretariat, Report of the 12 th meeting of the ACCSQ ? PPWG, 2007.

A. Hörner, General requirements for a new marketing authorisation application with focus on ASEAN, 2009.

A. Secretariat, Report of the 14 th meeting of ACCSQ ? PPWG, 2008.

D. Woo and . Stability-issues, Workshop on Medicinal Product Registration ? Updates and New Initiatives, 2008.

C. Ting, Experience of ASEAN Implementation ? an Industry Perspective. Industry Proposals: Industry Proposals: Long Term Goals, pp.14-15, 2009.

P. Russell, Country Q&A Thailand " , PLC Cross-border Life Sciences Handbook, p.347, 2009.