The TGA will consider evaluation reports from the bodies specified in Table 1 for use in the COB report-based process. This list has been determined by the Secretary for the purposes of regulation 16GJ of the Therapeutic Goods Regulations 1990.
This table must be read in conjunction with the requirements specified for the relevant application category and the Guidance on using evaluation reports from Comparable Overseas Bodies.
|
Body |
Country or jurisdiction |
How evaluation reports can be used |
|||
|---|---|---|---|---|---|
|
Safety |
Quality |
Efficacy |
Notes |
||
|
Australian Industrial Chemicals Introduction Scheme (formerly NICNAS) |
Australia |
Yes |
No |
No |
Reports may be used to support safety of substances proposed for use as ingredients in listed medicines (IN1 or IN2) when the substance is intended to be used as an excipient ingredient in sunscreens or other topical products. |
|
Cosmetic Ingredient Review (CIR) |
United States |
Yes |
No |
No |
Reports may be used to support safety of substances proposed for use as ingredients in listed medicines (IN1 or IN2) when the substance is intended to be used as an excipient ingredient in sunscreens or other topical products. |
|
European Food Safety Authority (EFSA) |
European Union |
Yes |
Yes |
No |
Reports may be used to support safety and quality of substances proposed for use as ingredients in listed medicines (IN1, IN2 or IN3) when the substance is intended for oral use. |
|
European Medicines Agency (EMA) |
European Union |
Yes |
No |
No |
Assessment reports for EU herbal monographs may be used to support safety of substances proposed for use as ingredients in listed medicines (IN1 or IN2) when the substance is a herbal material. |
|
Yes |
Yes |
Yes |
Reports for medicines submitted under Article 8(3) of Directive 2001/83/EC (full or full-mixed application, complete dossier) and assessed via the centralised procedure[1] may be used to support safety, quality and efficacy of registered complementary medicines (RCM2, RCM3 or RCM4) and efficacy of assessed listed medicines (L(A)2). |
||
|
Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) |
United States |
Yes |
Yes |
Yes |
Reports that form part of a New Drug Application may be used to support the safety, quality and efficacy of registered complementary medicines (RCM2, RCM3 or RCM4); safety and quality of substances for use as ingredients in listed medicines (IN1, IN2 or IN3); and efficacy of assessed listed medicines (L(A)2). |
|
Yes |
No |
No |
Assessment reports for monographs for OTC ingredients determined to be ‘Generally Recognized as Safe and Effective (GRASE)’ may be used to support the safety of substances proposed for use as ingredients in listed medicines (IN1 or IN2) |
||
|
Food Standards Australia New Zealand (FSANZ) |
Australia |
Yes |
No |
No |
Reports may be used to support the safety of substances proposed for use as ingredients in listed medicines (IN1 or IN2) when the substance is intended for oral use. |
|
Health Canada (HC) |
Canada |
Yes |
No |
No |
Reports for Natural Health Products may be used to support safety of substances proposed for use as ingredients in listed medicines (IN1 or IN2). |
|
No |
No |
Yes |
Reports for Natural Health Products may be used to support efficacy[2] of assessed listed medicines (L(A)2). |
||
|
Yes |
No |
Yes |
Reports for Natural Health Products may be used to support safety and efficacy[3] of registered complementary medicines (RCM3 or RCM4). |
||
|
Yes |
Yes |
No |
Assessment reports for Monographs from the Compendium of monographs may be used to support the safety and quality of substances proposed for use as ingredients in listed medicines (IN1, IN2 or IN3). |
||
|
Health Sciences Authority (HSA) |
Singapore |
Yes |
No |
No |
Reports for existing ingredients used in Chinese Proprietary medicines with a proposed new scope for use (e.g.: dose, therapeutic use, route of administration) or with emerging safety concerns may be used to support safety of substances proposed for use as ingredients in listed medicines (IN1 or IN2). |
|
Joint FAO/WHO Expert Committee on Food Additives (JECFA) |
Global |
Yes |
No |
No |
The WHO Technical Report Series and WHO Food Additives series (FAS) may be used to support safety of substances proposed for use as ingredients in listed medicines (IN1 or IN2) when the substance is intended for oral use. |
|
No |
Yes |
No |
Assessment reports for the FAO JECFA Monographs may be used to support quality of substances proposed for use as ingredients in listed medicines (IN1 or IN3) when the substance is intended for oral use. |
||
|
Pharmaceutical and Medical Devices Agency (PMDA) |
Japan |
Yes |
Yes |
Yes |
Reports for Category 1[4] OTC products (herbal medicines) may be used to support the safety, quality and efficacy of registered complementary medicines (RCM2, RCM3 or RCM4). |
|
No |
No |
Yes |
Reports for Category 1 OTC products may be used to support efficacy of assessed listed medicines (L(A)2). |
||
|
Yes |
Yes |
No |
Reports for Category 1 Quasi drugs (herbal medicines) may be used to support the safety and quality of registered complementary medicines (RCM3 or RCM4). |
||
|
Scientific Committee on Consumer Safety (SCCS) |
European Union |
Yes |
Yes |
No |
Reports may be used to support safety and quality of substances proposed for use as ingredients in listed medicines (IN1, IN2 or IN3) when the substance is intended to be used as an ingredient in sunscreens or other topical products. |
Footnotes
| [1] | See https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines#centralised-authorisation-procedure-section for information about the types of medicines that can be evaluated under the centralised procedure. |
|---|---|
| [2] | Health Canada reports to support efficacy must rely primarily on clinical trial reports, systematic reviews and meta-analyses to support the indications. |
| [3] | Health Canada reports to support efficacy must rely primarily on clinical trial reports, systematic reviews and meta-analyses to support the indications. |
| [4] | Category 1 products are those with new active ingredients only. |