BEBAC  Ing. Helmut Schütz


To the right pages are listed in chronological order. Pages below are ordered by topic. Obsolete documents are striken through.

General Guidances


  1. 2006-01-17 Update 2012-02-07 DKMA: 100% included in Con­fidence Interval; 90-111% for NTI-Drugs
  2. 2006-05-19 WHO: Fortieth Report
  3. 2006-05-31 HPFB: BE Requirements: Critical Dose Drugs
  4. 2006-07-27 EMEA: Questions & Answers Document to NfG on BA/BE
  5. 2006-11-24 NIHS: Revision of four Guidelines on BE and corresponding Questions & Answers Documents; new Guideline for Topicals
  6. 2007-05-24 EMEA: Recommendation on the need for revision of (CHMP) <NfG on the investigation of BA and BE>
  7. 2008-07-24 EMEA: Guideline on the Investigation of Bioequivalence, Revision of 2001 NfG (Draft)
  8. 2010-01-25 HPFB: Draft Guidance Documents: Conduct and Analysis of Comparative BA Studies, Comparative BA Standards: Formulations used for Systemic Effects
  9. 2010-01-29 EMA: Guideline on the Investigation of BE (Final)
  10. 2011-11-17 EMA: Appendix IV of Guideline on the Investigation of BE
  11. 2012-02-29 NIHS: Revision of four Guidelines on BE and corresponding Questions & Answers Documents; new Q&As on Ethical Combination Drug Products
  12. 2012-05-22 Update 2018-06-08 HPFB: Conduct and Analysis of Comparative BA Studies, Comparative BA Standards: Formulations used for Systemic Effects
  13. 2012-08-22 FDA: Draft Guidance: Self-Identification of Generic Drug Facilities, Sites, and Organizations
  14. 2013-03-15 EMA: Draft Guideline on the PK and clinical evaluation of MR dosage forms
  15. 2013-11-15 Update 2018-06-27 EMA: Product-specific guidance on the demonstration of BE
  16. 2013-12-04 FDA: Draft Guidance: BE Studies with PK Endpoints for Drugs Submitted Under an ANDA
  17. 2014-03-18 Update 2019-02-21 FDA: Draft Guidance: BA and BE Studies Submitted in NDAs or INDs — General Considerations

Biopharmaceutics Classification System

  1. 2006-05-19 WHO: Fortieth Report
  2. 2007-05-24 EMEA: Concept Paper on BCS-based Biowaiver
  3. 2008-04-25 WHO: Prequalification of Medicines Programme – Implementation of BCS
  4. 2012-08-21 HPFB: Draft Guidance Document – BCS Based Biowaiver
  5. 2015-08-01 Update 2018-08-09 FDA: Draft Guidance. Dissolution Testing and Specification Criteria for BCS Class 1 and 3 Drugs
  6. 2016-10-07 ICH: Concept Paper M9. BCS-based Bio­waivers
  7. 2017-12-21 FDA: BCS Based Biowaivers
  8. 2018-06-27 Update 2019-11-20 ICH: M9. BCS-based Biowaivers

Highly Variable Drugs

  1. 2006-04-27 Update 2008-07-03 EMEA: Concept Paper
  2. 2006-10-06 Update 2009-01-19 FDA: ACPS Meeting
  3. 2016-04-18 HPFB: Policy on Bioequivalence Standards for Highly Variable Drug Products


  1. 2012-02-09 FDA: Draft Biosimilar Guidances
  2. 2014-05-14 FDA: Draft Guidance on Clinical Pharmacology Data to Support a Demon­stration of Biosimilarity to a Reference Product
  3. 2014-10-23 EMA: Guideline on similar biological medicinal products
  4. 2017-01-17 FDA: Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product

Bioanalytical Method Validation

  1. 2009-11-19 Update 2011-07-11 EMA: Draft Guideline on Validation of Bioanalytical Methods
  2. 2013-09-13 Update 2018-05-21 FDA: Draft Guidance on Bioanalytical Method Validation
  3. 2016-10-07 Update 2019-02-26 ICH: Concept Paper M10. Bioanalytical Method Validation

Procedural / GxP

  1. 2006-05-23 HPFB: Records Related to Clinical Trials
  2. 2007-10-18 Update 2008-09-19 EMEA: Reflection Paper on Advice to Applicants/Sponsors/CROs of BE Studies
  3. 2009-08-03 EMEA/FDA: Joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities
  4. 2013-12-18 EMA/FDA: Joint initiative to share information on inspections of BE studies
  5. 2014-09-16 Update 2016-12-21 FDA: ANDA Submissions ― Refuse-to-Receive Standards


  1. 2009-01-22 Update 2015-11-19 EMA: Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on PK
  2. 2009-06-12 FDA: Website Redesign
  3. 2012-09-14 EMA: Draft guidelines on oral modified release products and transdermal patches (Section I: quality)
  4. 2013-12-04 FDA: Draft Guidance: Size, Shape, and Other Physical Attributes of Gene­ric Tablets and Capsules
  5. 2017-04-04 EMA: Draft Guideline therapeutic equivalence for locally applied and locally acting products
  6. 2017-04-05 EMA: Guideline on clinical development of fixed combination medicinal products
  7. 2017-10-24 FDA: Draft Guidances on Drug-drug interactions