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Is it possible to present preclinical data in IMPD and IB in different profundity? Date: 25. November 2008 Topics: Licensing Type: FAQ

If preclinical data are presented in the IB and the IMPD, both data sets should be equal or comparable. If in doubt, latest preclinical data should be presented in more detail or data in the IMPD.

Relevant differences of data in both …

Is it necessary to indicate changes in the new version of the IB and IMPD, regarding preclinical aspects? Date: 25. November 2008 Topics: Licensing Type: FAQ

Yes, providing only a brief list of changed sections is usually not sufficient for the assessment. The changes should be marked in the text of the new version (coloured, bold or underlined) or should be listed explicitly in detail.

What are the preclinical requirements for the IMPD layout? Date: 25. November 2008 Topics: Licensing Type: FAQ

IMPD layout should be in agreement with the layout suggestions in the 3. Notification on the clinical trial of medicinal products for human use.

For first in human studies is it necessary to submit safety margins based on exposure for the intended application? Date: 25. November 2008 Topics: Licensing Type: FAQ

Yes, the calculation of safety margins should be based on the estimated (upscaled) systemic exposure. In addition please give a statement about the expected therapeutic dose range in humans.

How to calculate the safe starting dose for first-in-human trials – does a European guideline exist? Date: 25. November 2008 Topics: Licensing Type: FAQ

Currently, a European guideline does not exist. Therefore, the FDA-guidance paper: ”Estimating the Maximum Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers” (July 2005) should be used. The dose calculation …

What kind of study design is expected if dosing of the investigational medicinal product in human is planned in cycles (e.g. for oncologic treatment) Date: 25. November 2008 Topics: Licensing Type: FAQ

In accordance with the ”Note for guidance on the pre-clinical evaluation of anticancer medicinal products“ (CPMP /SPW/997/96), drug application in repeated dose toxicity studies should be performed as similar as possible to the clinical study …

Are there any layout recommendations for presenting the results in the preclinical part? Date: 25. November 2008 Topics: Licensing Type: FAQ

Yes, tables are more suitable in reporting noteworthy findings, sorted by species, increasing duration of treatment, and increasing dose. These tables should also contain toxicokinetic data of the dose levels given as well as a statement on …

Is it possible to include women of childbearing potential in phase I/IIa trials without the assessment of embryo-foetal development? Date: 18. November 2008 Topics: Licensing Type: FAQ

Yes, this is possible in exceptional cases. If in the clinical trial

  • a life-threatening disease is treated and the patients involved are using highly effective contraception in accordance with Note 3 of the “Note for guidance on …

How should preclinical findings be presented and discussed? Date: 18. November 2008 Topics: Licensing Type: FAQ

Please do not present the findings sorted by target organs. Tables are more suitable in reporting noteworthy findings, sorted by species, increasing duration of treatment and increasing dose. Those tables should also contain toxicokinetic data …

Is it necessary to calculate safety margins for the intended application in humans? Date: 18. November 2008 Topics: Licensing Type: FAQ

Yes, it is necessary to present the calculated safety margins on the base of (free) exposure (AUC, Cmax) at the NOAEL in the animals to the expected exposure in the intended clinical trial. The safety margins should be calculated for the …

Is it necessary to submit the SmPC for all authorized IMPs for a CTA? Date: 11. November 2008 Topics: Licensing Type: FAQ

Yes, for the authorisation of clinical trials in humans with authorized investigational medicinal products which do or do not meet the conditions of authorisation (indication, type of application, dose range), SmPCs (in English and German) must …

Are there any requirements if the route of administration (e.g. oral to dermal) of an authorized investigational medicinal product is changed? Date: 11. November 2008 Topics: Licensing Type: FAQ

Yes, it may be necessary to submit additional information on local tolerance for the new route of substance administration. In any case, a risk-benefit assessment has to be submitted on the basis of systemic exposure.

Is it necessary to submit an absorption spectrum of the investigational medicinal product? Date: 10. November 2008 Topics: Licensing Type: FAQ

Yes, in the dossier an absorption spectrum of the investigational medicinal product in the wavelength range between 290 and 700 nm should be provided. In the case of light absorption >290 nm a statement about photosafety of the IMP in …

In-vitro-studies demonstrate a relevant blockade of the hERG-channel. What are the consequences for first-in-human trials and for further clinical applications? Date: 10. November 2008 Topics: Licensing Type: FAQ

A clinical trial is possible under the precondition of a careful dose escalation and an appropriate ECG monitoring according to the PK profile of the drug. The ICH documents S7B and E14 should be considered for non-clinical risk assessment and …

Are reproduction toxicity studies required for phase I trials which include women of childbearing potential Date: 10. November 2008 Topics: Licensing Type: FAQ

Yes, according to ICH M3(M) the assessment of embryo-foetal development should be completed prior to phase I trials.

E.1. Whom do I contact if I have questions regarding the sunset clause? Date: 17. September 2008 Topics: Licensing Type: FAQ

Questions not addressed in the FAQ or in the Explanatory Notes on Notification Procedures under the "Sunset Clause" can be sent to the e-mail address …

C.1. Can applications for exemption be granted with the justification that a medicinal product can/may not be marketed on "public health grounds"? Date: 09. September 2008 Topics: Licensing Type: FAQ

No. Exemptions can only be granted for medicinal products for which there is a public interest to maintain the marketing authorisation on "public health grounds“, e.g. so that such medicinal products are available in the event of a disaster.

C.5. For which period of time are exemptions granted? Date: 09. September 2008 Topics: Licensing Type: FAQ

As a rule, the decision on an exemption to the sunset clause is made on a case-by-case basis. Likewise, it is also dependent on the individual case for which period of time the exemption is granted. If the medicinal product is placed on the …

A.5. In which cases can the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG be suspended? Date: 09. September 2008 Topics: Licensing Type: FAQ

  1. It is the BfArM's view that the sunset clause period is suspended if the suspension of marketing authorisation was ruled for pharmacovigilance reasons. This suspension sets in automatically and is valid for the period of the ruling. The notification …

A.3. When does the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG start? Date: 09. September 2008 Topics: Licensing Type: FAQ

  1. In cases in which the medicinal product cannot be placed on the market yet e.g. due to existing patents, the BfArM follows the EMA's view that the start of the 3-year period should be the date when the medicinal product can actually be marketed. See …