Guidelines for allergen products – companies, specialist organisations, and patient advocates are invited to comment
The Paul-Ehrlich-Institut (PEI) points out two important regulatory documents in the area of test and therapy allergens which are currently published for commenting.
- The purpose of the draft guideline "Recommendations on common regulatory approaches for allergen products" is to support the EU member states to find more uniform regulatory approaches to allergen products and supplying patients with high-quality products for diagnoses and treatments of allergies.
The draft guideline was prepared by a group of the CMDh (Coordination group for Mutual recognition and Decentralised procedures – human) by the PEI (Professor Dr Stefan Vieths, vice president of the PEI, Professor Dr Vera Mahler, head of Division Allergology, and Dr Andreas Bonertz, head of Section Test and Therapy Allergens) and other specialists.
Parties interested are invited to comment by 03 Aug. 2019.
- The Rheumatology and Immunology Working Party of the European Medicines Agency (EMA) has published a concept paper on a Guideline for allergen products development in moderate to low-sized study populations. Since patients are often not sufficiently available in numbers sufficient to perform clinical studies, this activity helps develop approaches to showing feasible development programs. The aim is to support the development of medicines for diagnoses and therapies, including those which are extremely important for the respective patient groups but are used comparatively seldom.
As representatives of the PEI, Dr Andreas Bonertz and Dr Jan Müller-Berghaus have assumed the role of project managers in this working party for this project. The concept paper can be commented by 30 June 2019.
All companies, specialist organisations and patient advocates interested are invited to comment on these documents.
