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This is Attachment B 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 specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and 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. |
| 2001/83/EC as amended | 2001/83/EC | 1.1 | Update | The referenced guideline has been updated between 2006 and 2011. |
| It should be read in conjunction with the 'Guideline on quality of herbal medicinal products' (EMA/CPMP/QWP/2819/00, EMA/CVMP/814/00, EMA/HMPC/201116/2005, as revised). | It should be read in conjunction with the 'Guideline on quality of herbal medicinal products' (CPMP/QWP/2819/00 Rev. 1 and EMEA/CVMP/814/00 Rev. 1). | 1.1 | Update | The referenced guideline has been updated between 2006 and 2011. |
| 'Guideline on Good Agricultural and Collection Practice (GACP)' (AMEA/HMPC/246816/2005) and Good Manufacturing Practice (GMP). | Adherence to Good Agricultural Practice and Good Manufacturing Practice… | 1.1 | Update | Reference provided in updated version. |
| Includes analytical data on constituents such as constituents with known therapeutic activity. | Analytical data on constituents including constituents with known therapeutic activity. | 2.1.2 | Reword | Basic sentence restructure. |
| Mycotoxins (alfatoxins, ochratoxin A). | N/A | 2.1.3 | Text addition | |
| (Questions & answers (Q&A) on quality of herbal medicinal products/traditional herbal medicinal products (EMA/HMPC/41500/2010). | N/A | 2.2 | Text addition | Reference provided in updated version. |
| (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, EMEA/CVMP/VICH/10/04). | N/A | 2.4 | Text addition | Reference provided in updated version. 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. |
| (Microbial levels, mycotoxins (aflatoxins, ochratoxin A), toxic metals etc) | (Microbial levels, alfatoxins, heavy metals etc.) | 3.1.2 | Text addition | |
| (CPMP/ICH/2736/99 as revised). | (CPMP/ICM/2736/99) | 3.1.2 | Update | The referenced guideline has been updated between 2006 and 2011. |
| 'Guideline on stability testing of existing active substances and related finished products' (CVMP/QWP/122/02 and EMA/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). | 3.1.2 | Update | A 'note for guidance' exists before a guideline is officially adopted, the referenced guideline has been adopted between 2006 and 2011. |
| The ICH/VICH Guidelines 'Validation of analytical methods: definitions and terminology' (CPMP/ICH/381/95 and CVMP/VICH/590/98) and 'Validation of analytical procedures: methodology' (CPMP/ICH/281/95 and CPMP/VICH/591/98). | 'Note for guidance on validation of analytical procedures: text and methodology' (CPMP ICH/381/95)(or the corresponding VICH guidelines (CVMP/ICH/591/98). | 3.2 | Update | A 'note for guidance' exists before a guideline is officially adopted, the referenced guideline has been adopted between 2006 and 2011. |
| N/A | (herbal substances) | 3.2.1 | Reword | Basic in-text changes. |
| Whether it is wild or cultivated and the manufacturing process. | Its cultivation and the manufacturing process. | 3.2.1 | Reword | Basic in-text changes. |
| Heavy metals (2.4.27) should follow pharmacopoeial precedents. | Should follow pharmacopoeial precedents; other inorganic impurities may be determined by other appropriate procedures, e.g. Atomic absorption spectroscopy. | 3.2.1 | Reword | Basic in-text changes. |
| (aflatoxins, ochratoxin A): the potential for mycotoxins contamination should be fully considered. For aflatoxins, procedure and acceptance criteria should follow pharmacopoeial precedents (2.8.18) and for ochratoxin A, the procedure is described (2.8.22) and acceptance criteria are given in specific monographs. | The potential for mycotoxins contamination should be fully considered. Where necessary suitable validated methods should be used to control potential mycotoxins and the acceptance criteria should be justified. | 3.2.1 | Update | |
| Radioactivity: Radioactive contamination should be tested for if there are reasons for concerns. | N/A | 3.2.1 | Text addition | |
| 'Herbal drug preparations' | 'Herbal drug preparations' (herbal preparations) | 3.2.2 | Reword | Basic in-text changes. |
| (or current VICH guidance on residual solvents) | N/A | 3.2.2 | Text addition | Reference provided in updated version. |
| Whether it is wild or cultivated and the manufacturing process. | Its cultivation and the manufacturing process. | 3.2.2 | Reword | Basic in-text changes. |
| Where justified, procedures and acceptance criteria for Sulphated ash/Residue on ignition/Heavy metals (2.4.27) should follow pharmacopoeial precedents. | Ash/residue on ignition should follow pharmacopoeial precedents; other inorganic impurities may be determined by other appropriate procedures e.g. atomic absorption spectroscopy. | 3.2.2 | Reword | In-text changes. |
| Microbial counts should be determined using pharmacopoeial procedures or other validated procedures. The European Pharmacopoeia gives guidance on acceptance criteria. | These limits should comply with those in the European Pharmacopoeia. | 3.2.2 | Reword | Basic in-text changes. |
| (Aflatoxins, ochratoxin A): the potential for mycotoxins contamination should be fully considered. For aflatoxins, procedure and acceptance criteria should follow pharmacopoeial precedents (2.8.18) and for ochratoxin A, the procedure is described (2.8.22) and acceptance criteria are given in specific monographs. | The potential for mycotoxins contamination should be fully considered. Where necessary suitable validated methods should be used to control potential mycotoxins and the acceptance criteria should be justified. | 3.2.2 | Update | More references provided in updated version. |
| Impurities: Refer to the ICH ' Note for guidance on impurities in new drug products' (CPMP/ICH/2738/99)(or VICH guideline 'Impurities in new veterinary medicinal products', CVMP/VICH/838/99 as revised) and the European Pharmacopoeia general text on Residual solvents (or current VICH guidance on residual solvents) for detailed information. | Impurities: Refer to the ICH' Guideline on impurities in new drug products' (CPMP/ICH/2738/99) and the European Pharmacopoeia General text on Residual Solvents for detailed information. | 3.2.3 | Update | More references provided in updated version. |
| Toxic metals | Heavy metals | 3.2.4 | Reword | Basic in-text changes. |
| These microbial counts should be determined using pharmacopoeial procedures or other validated procedures. The European Pharmacopoeia gives guidance on acceptance criteria (5.1.8 for herbal medicinal products for oral use and 5.1.4 for other herbal medicinal products. | These limits should comply with the European Pharmacopoeia. The frequency of testing should be justified. | 3.2.4 | Update | More references provided in updated version. |
| Uniformity of mass: The pharmacopoieal procedure should be used. If appropriate, this test may be performed as in-process control; the acceptance criteria should be included in the specification. | Uniformity of dosage units: this term includes both uniformity of content and uniformity of mass; a pharmacopoeial procedure should be used. If appropriate, these tests may be performed as in-process controls; the acceptance criteria should be included in the specification. | 3.3.1.1 | Reword | In-text changes. |
| For guidance on acceptable limits, reference should be made to the European Pharmacopoeia general text on the Microbiological Quality of Herbal Medicinal Products for Oral Use (5.1.8). Periodic testing may be appropriate. | Reference should be made to the European Pharmacopoeia general text on the Mricrobiological Quality of Pharmaceutical Preparations for guidance on acceptable limits. Periodic testing may be appropriate. | 3.3.1.1 | Update | References updated in current version. |
| With acceptable scientific justification according to the Note for guidance on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemicals Substances (CPMP/ICH/367/96)(or VICH GL39: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: chemical substances, EMEA/CVMP/VICH/810/04), it may be possible to omit microbial testing for solid oral dosage forms. | With acceptable scientific justification, it may be possible to omit microbial testing for solid oral dosage forms. | 3.3.1.1 | Update | References updated in current version. |
| Uniformity of mass: Generally, acceptance criteria should be set for weight variation, fill volume, and/or uniformity of fill. Pharmacopoeial procedures should be used. | Uniformity of dosage units: This term includes both uniformity of content and uniformity of mass. | 3.3.1.2 | Reword | Basic in-text changes. |
| For guidance on acceptable limits, reference should be made to the European Pharmacopoeia general text on the Microbial Quality of Herbal Medicinal Products for Oral Use (5.1.8). | Reference should be made to the European Pharmacopoeia general text on the Microbiological Quality of Pharmaceutical Preparations for guidance on acceptable limits. Periodic testing may be appropriate. | 3.3.1.2 | Update | References updated in current version. |
| According to the Note for guidance on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemicals Substances (CPMP/ICH/367/96)(or VICH GL39: Test procedures and acceptance criteria for new vetinary drug substances and new medicinal products: chemical substances, EMEA/CVMP/VICH/810/04). | N/A | 3.3.1.2 | Update | More references provided in updated version. |
| '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). | 3.3.1.2 | Update | References updated in current version. |
| European Pharmocopoeia general text on the Microbiological Quality of Herbal Medicinal Products for Oral Use (5.1.8) for guidance on acceptable limits. | European Pharmacopoeia general text on the Microbial Quality of Pharmaceutical Preparations for guidance on acceptable limits. | 3.3.1.3 | Update | References updated in current version. |