EMA Publish Procedure for Calls for Scientific Data for Use in HMPC Assessment Work

Full Text Here

In accordance with Directive 2001/83/EC amended as regards traditional herbal medicinal products through Directive 2004/24/EC (1), it is the task of the Committee on Herbal Medicinal Products (HMPC) to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (Article 16f). Furthermore, the HMPC shall establish Community herbal monographs for herbal medicinal products (Article 16h(3)). The HMPC has also undertaken to ensure that monographs and list entries remain up-to-date (scientific state of the art) by assessing regularly the need for their revision (5, 6).
The legislation does not specify how scientific data relating to the assessment work for the monographs and list entries should be identified and compiled. The HMPC discussed a number of possibilities and agreed on a practice subject to 3 conditions:
1. The compilation of data will be a public procedure; and
2. The compilation will take place within a framework of criteria to be predefined by the HMPC (e.g. in relation to literature search strategy); and
3. The compilation shall seek to ensure that a complete set of bibliographic references and/or scientific data will be available to the Rapporteur(s).

No requirements for scientific standards are provided in the legislation and submission by interested parties of bibliographic references and/or scientific data is voluntary. However, some guidance as to the scope of data requested can be provided through the application of Directive 2001/83/EC:
Bibliographic data submitted in relation to well-established medicinal use should provide evidence that the constituent or the constituents of the medicinal product has or have a well-established medicinal use with recognised efficacy and an acceptable level of safety within the meaning of Directive 2001/83/EC as amended (Recital 2 of Directive 2004/24/EC).
Bibliographic data submitted in relation to traditional-use should provide evidence that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community (Article 16c(1)(c)).
In addition, the contributor is expected to submit both favorable and unfavorable data as well as to ensure that the newest publications are taken into account.
Further guidance on the requirements can be found in the HMPC ‘Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration’ (2) and the HMPC ‘Guideline on the assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well-established and of Community herbal monographs/entries to the Community list for traditional herbal medicinal products/substances/preparations’ (3).

For Assistance with Registering a Herbal Product in the EU or UK Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”