ASIA/ASIA PACIFIC/MIDDLE EAST
ASEAN States (ACCSQ): Pharmaceutical Product Working Group
o BA / BE: Final Draft Jul 2004
Australia (TGA): Guidelines
o Summary of a BA or BE Study: Dec 2002
China: SFDA
o Drug Administration Law: Dec 2001
o Regulations for Implementation of the Drug Administration Law: Sep 2002
o Good Clinical Practice: Aug 2003 zh
o Statistical Guidelines for Clinical Trials of Drugs and Biologics: Mar 2005 zh
o Hong Kong; GCP for Proprietary Chinese Medicines: Feb 2004
India (CDSCO): Central Drugs Standard Control Organization
o Bioavailability / Bioequivalence: Current Draft Mar 2005
o Submission of Clinical Trial Application for Evaluating Safety and Efficacy: v1.1 Dec 2008
Israel: MOH: Drug Registration Section
o Guidelines for Clinical Trials in Human Subjects: Jan 2006 (PDF888KB he, DOC462KB en)
o SOP for Performing BE in Human Subjects: Sep 2002 he
o Requirments for Registration of a Generic Product: Sep 2002 he
Japan (NIHS): Division of Drugs Guidances
o Clinical Pharmacokinetic Studies of Pharmaceuticals: Jun 2001
o Oral Prolonged Release Dosage Forms: Mar 1988
o Following guidelines were revised with 24 Nov 2006:
- BE Studies for Generic Products: Guideline ja Q&A Document ja
- Guideline for BE Test on Oral Solid Preparation for which the Formulation has been changed:Guideline ja Q&A ja
- Guideline for BE Studies of Adding Dosage Form for Topical Use: new 24 Nov 2006: Guideline ja Q&A ja
Jordan: Ministry of Health Rules & Regulations
o Laws and Regulations Applicable to the Conducting of Pharmaceutical Research: 2001 (Arabic)
Malaysia (BPFK): Guidelines
o Conduct of BA and BE Studies: Final, Sep 2000
o GCP: Second Edition, Jan 2004
o GLP: Draft Jul 2006
o Guidance Document and Guidelines for Registration of Biosimilars: Aug 2008
New Zealand (Medsafe): Guidelines
o Biostudy Reference Products: Jul 2006
Saudia Arabia: Saudi Food & Drug Authority
- BE: Draft May 2005
- Clinical Trials Guideline: Draft May 2005
- GLP: Draft Feb 2006
- Drug Master File Requirements for the Registration of Biosimilars: Draft Aug 2007
Singapore: HSA
o Drug Registration Information and Guidelines
- ASEAN Common Technical Requirements (ACTR)
Validation of Analytical Procedures: Final, Jan 2005
South Korea: KFDA
o Minimum Requirements for BE Test: Dec 2005
Taiwan: CDE Regulations in zh
- BA / BE: Dec 2006
- GCP: Jan 2005
- Pediatric PK: Jul 2002
- Ethnic Factors in the Acceptability of Foreign Clinical Data: May 2002
- GLP: Mar 2006
- Nonclinical Pharmacology/Toxicology: Jun 2000
- Analytical Method Validation: Jan 2000
Thailand (FDA): DCD
o BE Study Protocol / Report: 2003 th
o BA / BE: Aug 2004, adopted 2005
o Instruction for the In Vivo BE Study Protocol Development: Oct 2006 th
EUROPE
European Union (EMEA)
EudraLex – The Rules Governing Medicinal Products in the European Union
o Guidelines: Clinical Efficacy and Safety
o Guidelines: Multidisciplinary
o Legislation
- Directive 2001/20/EC (Implementation of GCP in the Conduct of Clinical Trials on Medicinal Products for Human Use): Apr 2001
- Directive 2003/94/EC (Principles and Guidelines of GMP in Respect of Medicinal Products for Human Use and Investigational Medicinal Products for Human Use): Oct 2003
- Directive 2004/9/EC (Inspection and Verification of GLP): Feb 2004
- Directive 2004/10/EC (Harmonisation of Laws, Regulations and Administrative Provisions relating to the Application of the Principles of GLP and the Verification of their Applications for Tests on Chemical Substances): Feb 2004
- Directive 2005/28/EC (Principles and detailed Guidelines for GCP as regards IMPs for Human Use, as well as the Requirements for Authorisation of the Manufacturing or Importation of such Products): Apr 2005
- Requirements to the Chemical and Pharmaceutical Quality Documentation concerning IMPs in Clinical Trials: Mar 2006
- Definition of IMPs and NIMPs: Jul 2006
- Additional Information on IMPs: Apr 2007
o Bioavailability / Bioequivalence
- Note for Guidance and associated documents
Bioavailability / Bioequivalence: Jul 2001
Bioequivalence: Draft Jul 2008
Questions & Answers on the BA and BE Guideline: Jul 2006
Recommendation on the Need for Revision of NfG on BA/BE: May 2007
Concept Paper on BCS-based Biowaiver: May 2007
Advice to Applicants/Sponsors/CROs of BE Studies: Sep 2008
o Pharmacokinetics
- Pharmacokinetic Studies in Man: Oct 1988
- PK Studies in Patients with Renal Impairment: Jun 2004
- Evaluation of the PK of Medicinal Products in Patients with Impaired Hepatic Function: Feb 2005
- PK in the Development of Medicinal Products in the Paediatric Population: Jun 2006
- Reflection paper: Use of Pharmacogenetics in the PK Evaluation of Medicinal Products: May 2007
- Concept Paper on the Development of a Guideline on the Use of Pharmacogenomic Methodologies in the PK Evaluation of Medicinal Products: Apr 2009
- Reporting Results of Population PK Analyses: Jun 2007Strategies to Identify and Mitigate Risks for First-In Human Clinical Trials with IMPs: Jul 2007
o Statistical Issues
- Biostatistical Methodology in Clinical Trials: Oct 1993
- Points to Consider on Multiplicity Issues in Clinical Trials: Sep 2002
- Points to Consider on Missing Data: Nov 2001
- Guideline on Missing Data in Confirmatory Clinical Trials: Draft Apr 2009
o Miscellaneous
- Q&A: Positions on specific questions addressed to the EWP therapeutic subgroup on Pharmacokinetics: Jul 2009
- Scientific Advice & Protocol Assistance: Revision 5, Jan 2009
- Letter of Intent Template
- Concept Paper/Recommendations on the Need for a (CHMP) Guideline on the Validation of Bioanalytical Methods: Dec 2008
- Test on Samples of Biological Origin: Jul 1989
- Validation of Analytical Procedures.
Definition and Terminology: Jun 1994
- Clinical Investigation of Chiral Active Substances: Apr 1994
- Topicals: Nov 1995
- Fixed Combination Medicinal Products: Feb 2009
- Drug Interactions: Dec 1997
- Concept Paper/Recommendation on the Need for Revision of NfG on the Investigation of Drug Interactions: Jul 2008
- Development Pharmaceutics: Jan 1998
- Dry Powder Inhalers: Jun 1998
- Recommendation on the Need for Revision of Points to Consider on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP): Feb 2007
- Requirements for Clinical Documentation for Orally Inhaled Products (OIP) including the Requirements for Demonstration of Therapeutic Equivalence between two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD): Jan 2009
- Gender Considerations in the Conduct of Clinical Trials: Jan 2005
- Biosimilars: Oct 2005
- Q&A on biosimilar medicines: Oct 2008
- Clinical Investigation of the PK of Therapeutic Proteins: Jan 2007
- Inspections – Good Clinical Practice: Set of 13 documents, Sep 2007 - May 2008
- Heads of Medicines Agencies / Human Medicines
All pages refer to current documents (PDF).
Application for Marketing Authorisation (MA)
EDQM: Quality Assurance Activities Guidelines
o Validation of Analytical Procedures: Jun 2005
o Uncertainty of Measurements
o Qualification of Equipment (core document): Sep 2008
Denmark DKMA: Guidelines and Forms
o Bioequivalence and labelling of medicinal products with regard to generic substitution: Jan 2006
Netherlands (GBG-MEB): Legislation & Guidelines
o Exemptions from BE-testing (positive list): for strict national registration only: Jan 2008
Switzerland: Swissmedic
o Instructions for Generics: Dec 2002
o Reference Formulations for BE / CTDs for Generics: Apr 2004
Federal Office of Public Health, AGIT : Guidelines on computerized systems
o Guidelines for the archiving of Electronic Raw Data in a GLP Environment: May 2003
o Guidelines for the management of electronic SOPs in GLP: Sep 2006
o Guidelines for the acquisition and processing of electronic raw data in a GLP environment: Sep 2006
o Guidelines for the validation of computerised Systems in GLP Environment: Dec 2007
Turkey: Ministry of Health
o Good Laboratory Practice Principles: Jun 2002 tr
o Licensing Regulation for Pharmaceutical Products: 2003
o Submission of BA/BE Dossiers: Jan 2006
LATIN AMERICA
Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
o GCP Guideline for studies in human subjects: Nov 2007 es
o Good Practices in Clinical Pharmacology Research: Feb 2008 es
o BA / BE: Final Sep 2006, amended Mar 2007 es
o Bioanalytical Method Validation: Final, Sep 2005 es
Brazil (ANVISA): Legislation
o Implementation of Relative BA and BE Studies: Apr 2006
o Pharmaceutical Equivalence / Dissolution: Sep 2004
o Exemption and Substitution of BE Studies: May 2003
o Bioanalytical Method Validation: May 2003
o Explanation of the Implementation of Re No. 899/2003 – Validation of Bioanalytical Methods: Jun 2008
o Statistics for BA/BE Studies: May 2003
o Protocol of BE Studies: May 2003
o Report of BE Studies: May 2003
o List of Reference Products: Current
o Rules / Technical Regulations for CROs: May 2003
Annex I: Certification for BA/BE Centers:
Annex II: Guidelines for Inspection at Centers of BA/BE of Medicines
Annex III: Certificate of Good Practices of BA/BE of Medicines
Annex IV: Form for Outsourcing of Phase for Assays of BA/BE of Medicines
Annex V: Form for Monthly Report of Assays of BA/BE of Medicines
o Guidance for Pharmaceutical Equivalence and Bioequivalence of Nasal Sprays and Aerosols: Jun 2008
- Volume 1 (clinics, analytics, statistics): 2002
- Volume 2 (micropipets, water for analysis, instrumentation): 2002
Mexico: Secretaría de Salud
o BA / BE: Final, May 1999
o BA / BE Update, Biowaivers: Mar 2000 es
o Comisión Permanente de la Farmacopea de los Estados Unidos Mexicanos: Legislación santitaria relacionada con la industria farmacéutica es
