New Harmonisation Guideline for the Regulation with Regard to Allergen Products in Europe has been published

Professor Stefan Vieths, vice president of the Paul-Ehrlich-Institut and chairman of the allergen working party of the CMDh states: "The guideline developed under the supervision of Dr Andreas Bonertz, head of Section “Test and Therapy Allergens” is an important milestone and an efficient tool that significantly improves the availability of safe and efficacious allergen products in the EU." Regulatory authorities and manufacturers use this guideline to find answers to questions such as: Which regulatory procedures should be used for different products (test and therapy allergens)? How can certain procedures be planned in an efficient manner? Under what circumstances are individual preparations expedient? A list of allergens recommended for a full marketing authorisation completes the guideline.

As a scientist and medical doctor, Professor Vera Mahler, head of Division Allergology is in a position to cover the whole range from research to the treatment of patients. She states: "We were able to make a major contribution to all aspects of the guideline from clinical practice, research right down to our expertise in marketing authorisation and testing."

Different handling between European countries

Standardised and industrially produced allergen products manufactured in batches require a marketing authorisation, while individual preparations prepared on prescription for treatment or test allergens for the recognition of rare allergies do not. The classification of allergen products into these two categories is often not carried out in a uniform manner in the EU member states: In some countries, the exception for individual preparation is used so extensively that there are hardly any products with a marketing authorisation. In Germany, a marketing authorisation is required for all individual preparations based on the Therapy Allergen Regulation (Therapieallergene-Verordnung, TAV) available on the market for the treatment of common allergies, since this is the only way in which an authority can test the quality, efficacy, and safety of allergy products independently.

Project on a broad European basis

The CMDh Allergen Group was initiated by the Coordination Group for Mutual Recognition Decentralised Procedures - human; CMDh), which is part of the association of the Heads of Medicine Agencies; HMA throughout Europe. At first, an enquiry was made by the European Medicines Agency (EMA), and the European Commission also expressly supported the plan. The Paul-Ehrlich-Institut, which is the only European regulatory authority with an Allergology Division, has made major contributions to the guideline. Representatives of various European countries as well as the EMA were involved in the CMDh Allergen Group. The guideline was adopted with the involvement of all EU member states as well as based on the public comments by industries, professional associations, and other interested parties.