Regulation of new excipients in topical non-prescription medicines

This consultation opened on 28 November 2005 and closed on 16 December 2005. It remains on this website as a historical reference.

The TGA sought comments on proposed changes to the existing policy on the regulation of new excipients in topical non-prescription medicines.

Under this policy sponsors are allowed to include new excipients in topical non-prescription medicines without first having their toxicology assessed if:

• The ingredient is named in the International Cosmetic Ingredient Dictionary (ICID);
• The sponsor gives certain assurances; and
• The sponsor agrees to provide the required data within six months of the date of listing/registration of the product.

The policy was introduced in 1993 to facilitate the regulation of sunscreens and other topical OTC medicines. At that time all new excipients had to be evaluated by the prescription drug stream. It was intended as a short term measure for chemical ingredients only. However, the policy remains force and has expanded to incorporate biological and herbal ingredients, as these now appear in the ICID.

The policy required the creation of a new ingredient category, 'PRV', to distinguish these ingredients from approved names for which a toxicological profile had been accepted. There is no equivalent process in New Zealand.

Problems with the current policy

1. Products can be listed with new excipients without any evaluation of toxicological data. If the data are not acceptable, or not submitted within 6 months, the product can be cancelled. This creates uncertainty for sponsors.
2. A backlog of around 200 data packages had built up by December 2004 leading to delays of several years before the data were evaluated. This backlog has now been cleared.
3. Different sponsors may have used the same excipient - in some cases we have received 10 or more different data packages for the same excipient. Each sponsor has to pay an evaluation fee of $5270.00.
4. The data were often of poor quality, necessitating ongoing dialogue with the sponsor or their agent. Some sponsors get a 'free ride' if another sponsor submits a better data package.
5. Some sponsors would launch the product for one season then withdraw it before being challenged to provide the data.
6. Many sponsors have not provided the data within the required time. One sponsor has over 100 data packages outstanding since 2002, another has over 80. The OTC Section has recently sent letters to 21 sponsors in this regard.
7. This exposes the agency, and the industry, to the risk of criticism if there are adverse reactions to a product containing a new excipient and this could have been predicted from the data.
8. Entries in the ICID are often insufficient to adequately identify the ingredient concerned, especially for biological and herbal ingredients. This can potentially lead to substitution of ingredients (all of which meet the definition of the ICID), which may have safety implications. In addition, the naming of herbal ingredients in the ICID is not in accordance with the TGA's herbal naming policies.

CMEC consideration

The CMEC (at its 39th meeting) considered this issue in relation to new herbal excipients in listed products. The committee agreed that the TGA should undertake pre-market evaluation of all excipients used in listed topical medicines, noting that consultation with industry would be required.

Issues to be considered

Removal of the current policy would have the following benefits:

• Industry would have greater certainty that their products would not be under threat pending evaluation of their data package;
• Consumers could have greater confidence in the safety of their topical medicines;
• Ingredients would be identified correctly, leading to greater certainty that the product is being formulated appropriately;
• Naming of ingredients (particularly biological and herbal names) could follow the usual guidelines and not be restricted to the ICID terminology;

Because the OTC backlog has now been cleared, new applications can be dealt with before listing / registration of the product without unduly delaying the process. The target evaluation time for OTC medicines, using a fast-track procedure, is 4 weeks

In addition, current proposals to regulate most secondary sunscreens as cosmetics will substantially reduce the number of new excipient applications (most of these have been in secondary sunscreens).

Proposed strategy

We propose to discontinue the current policy for new excipients from 31 December 2005. This will mean that the last data package will be due before the Joint Agency commences on 1 July 2006.

After 31 December 2005, sponsors who wish to include new excipients in topical non-prescription medicines will need to submit the required toxicological data prior to or concurrently with the listing / registration application. The application will not be approved before the excipient is cleared.

The TGA will give priority to reviewing the data (target time 28 days) so as not to unduly delay the application process.