Such studies are also conducted to support formulation selection and development. Deciding on the best site or geographical area in which to conduct the trial is key. While timelines and budgets are important, other factors must be taken into account, as will be explained in this paper. Although the focus here is on bioequivalence studies, most of the requirements and considerations discussed are applicable to other Phase I trials as well.
The first question is, where will the product be registered? This white paper focuses on trials that will support registration of a medicinal product in the EU. In such cases, regional authorities establish trial requirements as set forth in the marketing authorization application (MAA). For drug applications in the US, via abbreviated new drug applications – abbreviated new drug applications (ANDAs), the regulatory requirements are similar but based on a separate set of laws.
The three key essentials for clinical trials supporting registration in the EU are:
As long as these three principal requirements are upheld, the investigational site may be located anywhere in the world. The following sections explain in more detail what meeting these conditions involves.
EU and non-EU trial sites can be inspected by EU GCP inspectors at the request of EU regulatory agencies. Trial sites must fully facilitate such inspections, providing access to all information requested by the inspectors and responding to questions or findings in a timely and constructive manner.
For MA applications, EU regulatory agencies accept studies conducted in non-EU countries if the studies meet compliance criteria equivalent to those required of trials conducted in the EU, and the study design supports EU product registration.
Selecting the location of a clinical Phase I trial site is a case-by-case decision, and pros and cons vary for different situations.
There are 3 Key Requisites for consideration in this decision: Ethical Standards and GCP Requirements, Valid Trial Design and Conduct, and Local Requirements. Meeting and exceeding those considerations is critical for seamless movement past Phase 1 and towards EU regulatory approval.
1. EMA Guideline on Bioanalytical Method Validation (https://www.ema.europa.eu/en/bioanalytical-method-validation).2. EMA Guideline on Bioanalytical Method Validation Draft for comment: https://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation
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