Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Implications of the German Regulation on Therapy Allergens ("Therapieallergene-Verordnung") on the allergen manufacturing industry

Dr. Dorothee Klinkowski (Abschlußjahr: 2011)

Language: English

According to article 21 (2), 1g of the German Drug Law, therapy allergen products for specific immunotherapy (SIT) are generally exceptions with regard to obtaining marketing authorization, due to individual prescription. After enactment of the Regulation on Therapy Allergens (Therapieallergene-Verordnung, TAV) on November 14th 2008, the legal basis changed in Germany. The overall aim is to achieve marketing authorization for most Named Patient Products (NPPs) currently on the market without authorization. The affected allergens are listed in the annex of the TAV. Products containing one or more listed allergens are subject to marketing authorization and official batch release.

Therapy allergen manufacturing companies as well as the PEI have to deal with a lot of implications of the TAV. Companies had to follow strict timelines complying with all requirements of the TAV. By May 14th 2009 at the latest, products intended for marketing authorization had to be notified to the PEI, accompanied by quality documentation. All products not being notified had to be withdrawn from the market. By October 2009 at the latest, all bulks of notified products were subject to official batch testing. Batch releases will be performed with the respective bulks. All products marketed after October 1st 2009 had to be manufactured using officially approved bulks only. By December 1st 2010 marketing authorization applications of all notified products had to be submitted to the PEI. One important formal condition was that an approved PIP to be included in MAAs. Facilitating the PIP procedure, and as a result of the high number of PIP submissions, a standard PIP was established by the EMA. The requirements of the standard PIP are complex. Primarily, long-term studies have to be performed for all required adult studies and a minimum one paediatric study being representative for companies portfolio. Waivers are granted for children of less than five years of age. Companies have up to seven years for finalizing clinical development (estimated until 2018/2019) after receiving a deficiency letter for a MAA. Paediatric development is excluded if deferrals had been applied for. The financial burden regarding clinical development is increased substantially.

Pages: 37 Annexes:0