Biology Subcommittee under the Danish Pharmacopoeia Commission

06 October 2016

To support the Danish Medicines Agency’s work related to pharmacopoeia, the Danish Pharmacopoeia Commission will set up a new subcommittee with special expertise in biochemistry and biological medicinal products.

The subcommittee will operate in parallel with the existing subcommittees for pharmacy, pharmacognosy and chemistry.

Consequently, the Danish Medicines Agency is seeking nominations for members of the Biology Subcommittee for the period from 1 January 2017 to 31 December 2019.

Anyone can nominate members to the subcommittee, and self-nomination is also possible.

About the subcommittees

The subcommittees under the Danish Pharmacopoeia Commission, including the Biology Subcommittee, provide answers, offer advice and professional assistance etc. to the Danish Medicines Agency.

The Biology Subcommittee will offer advice to the Danish Medicines Agency about technical and quality aspects of biological medicinal products and related raw and intermediate products as well as about vaccines, allergenic products etc. The work will be closely related to the development and updating of monographs for the European Pharmacopoeia.

In principle, the subcommittees can discuss all professionally relevant topics within or across their competencies, however, it should be emphasised that the subcommittees do not make decisions, but only play an advisory role.

In practice, the subcommittees operate within a clear framework and meet four times a year with representatives (covering licensing, inspection and laboratories) of the Danish Medicines Agency, which serves as secretariat to the Danish Pharmacopoeia Commission and its subcommittees.

The meetings are synchronised with the publication of the EDQM’s ”Pharmeuropa” with proposals for future pharmacopoeia monographs.

The secretary selects the proposed monographs that the individual subcommittees are to comment on and make a risk assessment of. The results of this work are discussed at the meetings and prepared as recommendations for the EDQM.

In addition, the laboratory of the Danish Medicines Agency will use the risk assessment for its risk-based selection of APIs, excipients and products for control.

In connection with the EDQM’s monograph development, a number of Danish experts from the Danish Medicines Agency, universities, industry etc. will participate in the work at the Danish Medicines Agency. The experts must be members of one of the four subcommittees. Any expert work, which is relevant to a subcommittee, will be presented at the meetings.

Moreover, the subcommittees will be involved, where relevant, in the development/amendment of the executive order ”Danish Drug Standards”.

If any requests or complaints about a product to the Danish Medicines Agency require special knowledge, a subcommittee may be consulted, either via the chairman or directly to a member who has this specific knowledge.

Members and competencies

We are seeking nominations for members with considerable experience in the formulation, development, manufacturing or quality control of biological (including biosimilars) and related medicinal products.

The subcommittee members are expected to have up-to-date and preferably hands-on knowledge of a large or small area of a subcommittee’s field.

Recommendation of members for both councils and subcommittees will be based on professional background as well as practical experience with the development and manufacturing of medicinal products. Members will be recommended on the basis of their personal competencies and relevant experience.

The work in the Biology Subcommittee is unpaid. The Chairman of the Biology Subcommittee will become a member of the Danish Pharmacopoeia Commission and will receive remuneration for this membership in accordance with the Danish Government regulations.

Submission of nominations

Please send nominations for members to the Danish Medicines Agency no later than 21 October 2016.

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