BEBAC  Ing. Helmut Schütz

Revision of Guidelines

Japan – NIHS

On 29 February 2012 Japan’s NIHS published revisions of BE Guidelines and corresponding Questions & Answers Documents (of Nov 2006), as well as new Q&As.

Revised Guidelines:

  1. Guideline for BE Studies for Generic Products (GL, Q&A)
  2. Guideline for BE Studies of Generic Products for Different Strengths of Oral Solid Dosage Forms (GL, Q&A)
  3. Guideline for BE Studies for Formulation Changes of Oral Solid Dosage Forms (GL, Q&A)
  4. Guideline for BE Studies for Different Oral Solid Dosage Forms (GL, Q&A)

New Questions & Answers Documents:

  1. BE Studies of Generic Products for Ethical Combination Drug Products (Q&A)
  2. BE Studies for Different Strengths of Ethical Combination Drug Products and Formulation Changes of Ethical Combination Drug Products (Q&A)