This is Attachment A of the consultation: TGA adoption of two European Union (EU) scientific guidelines for herbal medicines.
| Rev 2, 2011 (current) | Rev 1, 2006 | Section | Type of amendment | Further information |
|---|---|---|---|---|
| Explanatory note on revision 2: Minor corrections updating the CPMP/CVMP/QWP 'Guideline on quality of herbal medicinal products' were introduced, which take into account new and revised guidelines, the European Pharmacopoeia revised general monograph 'Herbal Drugs', as well as new requirements for impurities. Given the nature of this update, a concept paper or public consultation was not required. | N/A | Page 2 | Text addition | Gives an overview of all changes made between the 2006 and 2011 versions of the document. |
| 'Guideline on the use of the CTD format in the preparation of a registration application for Traditional Herbal Medicinal Products' (EMA/HMPC/71049/2007). | N/A | Introduction | Text addition | |
| Or 2001/82/EC as amended. | Or 2001/82/EC | 5.1 | Update | The referenced guideline has been updated between 2006 and 2011. |
| For mycotoxins (alfatoxins, ochratoxin A) | N/A | 5.1 | Text addition | |
| EMEA/CVMP/134/02 as revised | EMEA/CVMP/134/02 | 5.1 | Update | The referenced guideline has been updated between 2006 and 2011. |
| For mycotoxins (alfatoxins, ochratoxin A) | N/A | 5.1 | Text addition | |
| CHMP/QWP/297/97 as revised | CHMP/QWP/297/97 Rev. 1 corr | 5.1 | Update | The referenced guideline has been updated between 2006 and 2011. |
| 'Guideline on excipients in the dossier for application for application for marketing authorisation of a medicinal product' (Eudralex 3AQ 9A). | 'Note for guidance on excipients in the dossier for application for marketing authorisation of a medicinal product' (Eudralex 3AQ 9A). | 5.3 | Update | A 'note for guidance' exists before a guideline is officially adopted, the referenced guideline has been adopted between 2006 and 2011. |
| 'Guideline on specifications and control tests on the finished product' (Eudralex 3AQ 11A). | 'Note for guidance on specifications and control tests on the finished product' (Eudralex 3AQ 11A). | 7 | A 'note for guidance' exists before a guideline is officially adopted, the referenced guideline has been adopted between 2006 and 2011. | |
| The control tests on the finished product should allow the qualitative determination of the active substance(s). | The control tests on the finished product should allow the qualitative and quantitative determination of the composition of the active substance(s). | 7 | Text removed | Basic editing of text does not alter the meaning of the sentence. |
| According to the (V)ICH Notes for guidance on Specifications: (Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, (CPMP/ICH/367/96, and Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances, EMA/CVMP/VICH/10/04) | N/A | 7 | Text addition | Please note that "Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances, EMA/CVMP/VICH/10/04" is not applicable to TGA, as TGA does not regulate medicines for veterinary use. A reference has been provided so that frequency of testing for microbial contamination can be justified. The 2006 version did not supply a reference. |
| 'Note for guidance on stability testing of new active substances and products' (CPMP/ICH/2736/99 as revised). | 'Note for guidance on stability testing of new active substances and products' (CPMP/ICM/2736/99 Rev. 2). | 8 | Update | A 'note for guidance' exists before a guideline is officially adopted, the referenced guideline has been adopted between 2006 and 2011. |
| 'Guidance on stability testing of new veterinary drug substances and medicinal products' (CVMP/VICH/899/99 as revised). | 'Guidance on stability testing of new veterinary drug substances and medicinal products' (CVMP/VICH/899/99). | 8 | Update | Please note that TGA does not regulate medicines for veterinary use. |
| 'Guideline on stability testing of existing active substances and related finished products' (CPMP/QWP/122/02 and EMEA/CVMP/846/99 as revised). | 'Note for guidance on stability testing of existing active substances and related finished products (CPMP/QWP/122/02 Rev. 1 and EMEA/CVMP/846/99). | 8 | Update | A 'note for guidance' exists before a guideline is officially adopted; the referenced guideline has been adopted between 2006 and 2011. |