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Consultation: TGA adoption of two European Union (EU) scientific guidelines for herbal medicines

5 February 2015

This consultation closed on 10 April 2015

The TGA sought comments from interested parties on the proposed adoption of two European Union guidelines as guidance material for sponsors and manufacturers of medicines including herbal ingredients.

Consultation documents

How to access a pdf or Word document

Timetable

Documents released for consultation Friday 6 February 2015.

Consultation closes Friday 10 April 2015.

About the consultation

We aim to align our regulatory approach to therapeutic products with those of comparable international regulatory counterparts wherever possible. We have approximately 300 current adopted EU scientific guidelines.

The TGA has previously adopted the 2006 versions of the above documents (CPMP/QWP/2819/00 Rev. 1 and CPMP/QWP/2820/00 Rev. 1). As these publications have been superseded by 2011 revisions, it is appropriate to consider if we should adopt the recent versions as our guidance material.

The EU Guidelines listed above provide guidance to applicants on the data required to establish the quality of herbal materials. Compliance with these guidelines expedites the application processes for new listable herbal ingredients and registered complementary medicines with herbal ingredients.

Attachment A and Attachment B list the changes between the 2006 and 2011 documents. As the changes appear minor in nature, it is likely that the adoption of the 2011 versions will not increase regulatory burden.

Please note that EU legislation references in these guidelines are not applicable to therapeutic goods regulated by Australian legislation. Further, if these guidelines are adopted, all Australian legislative requirements remain applicable.

Content of submissions

We are seeking the following input:

  1. Do you support the adoption of the two 2011 EU scientific guidelines? If not, please provide information why and suggest an alternative acceptable to you. For example, should the guidelines be adopted only in part or with annotations?
  2. Will the adoption of the guidelines positively or negatively impact you? That is, what are your likely benefits or costs (financial or non-financial)? If possible, please quantify your costs and benefits.
  3. Do you have any other comment on the adoption of the two 2011 EU scientific guidelines?

What will happen with your submission

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA Internet site.

Privacy infomation

  1. The TGA collects your personal information in this submission in order to:
    1. contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    2. help provide context about your submission (for example: to determine whether you are an individual or a director of a company or representing an interest group).
  2. The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (that is, make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the coversheet).
  3. Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  4. Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed to the Complementary Medicines Branch by email OCM@tga.gov.au or by telephone to 02 6232 8634.