Drug Regulators, EMA (EMEA), Publish Draft Guidance on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
Full Text Here
This guideline outlines the requirements for the data to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Products (IMP) containing biological / biotechnology derived substances. In the EU, applications to conduct clinical trials are required to be submitted to the competent authority for approval prior to beginning a clinical trial in separately in each member state in which the trial is proposed to take place. Approval of trials is the responsibility of each involved Member State. This guideline aims to ensure harmonised requirements for the documentation to be submitted throughout the European Community. Available guidelines on the quality of biological / biotechnological medicinal products mainly address quality requirements for marketing authorisation applications. This guidance may not be fully applicable in the context of a clinical trial application; however the principles outlined in these guidelines are applicable and should be taken into consideration during development. A guideline on virus safety (EMEA/CHMP/BWP/398498/05) giving advice on the requirements for viral safety of IMP is available. The guideline on Strategies to Identify and Mitigate Risks for First-In-Human Clinical Trials with Investigational Medicinal Products (EMEA/CHMP/SWP/28367/07, current version) is also relevant. Assuring the quality of biological medicinal products is challenging, as often they consist of a number of product variants and process related impurities and it is difficult to predict the safety and efficacy profile of these variants and process related impurities. Unlike chemical entities, toxic impurities are generally not an issue, and the safety issues are more often related to the mechanism of action of the biological product or to immunogenicity. In the context of an overall development strategy, normally several clinical trials, using products from different versions of the manufacturing process, will be initiated to generate data to support a Marketing Authorisation Application. The objective of this document is to address the quality requirements of an investigational medicinal product for a given clinical trial, not to provide guidance on a Company’s overall development strategy for a medicinal product. Nevertheless, for all clinical development phases, it is the responsibility of the applicant (sponsor) to ensure protection of the clinical trial subjects using a high quality IMP that is suitable for its intended purpose, and to appropriately address those quality attributes that may impair patient’s safety (e.g. microbiological aspects, contamination, dose). There are clear differences between the requirements for a dossier for a clinical trial and a marketing authorisation dossier. Whilst the latter has to ensure a consistent, state-of-the-art quality of a product for widespread use in patients, information to be provided for an IMP should mainly focus on those quality attributes related to safety aspects. The extent of the information required for an IMP Dossier (IMPD) should take into account the nature of the product, the state of development / clinical phase, patient population, nature and severity of the illness as well as type and duration of the clinical trial itself. When compiling the quality part of the IMPD for phase II and phase III clinical studies, the wider exposure of patients to the product and the progressive product knowledge have to be taken into account compared to phase I clinical studies. Based on the diversity of products to be used in the different phases of clinical trials, the requirements defined in this guideline can only be taken as illustrative and cannot be expected to present an exhaustive list. IMPs based on innovative and/or complex technologies may require a more detailed data package for assessment.
For Assistance with Regulatory Planning and Execution of Clinical Trials Click Here
Damien Bové is the drug development and regulatory consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Fill Out the Short Form Below…
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”