Investigational medicinal products IMPs

Most of the information sought is similar to the FDA s IND requirements. One major difference is that a Qualihed Person has to certify that the investigational medicinal product (IMP) is manufactured according to GMP The Competent Authority has the right to inspect the manufacturing facility for GMP compliance, the preclinical facility for GLP compliance, and the clinical trial sites for GCP compliance. 

Clinical trials are regulated by individual member states in the European Union. An applicant (or sponsor) submits data on the investigational medicinal product (IMP), and details of the proposed clinical trial, to the competent authority in the country in which the trial is to be carried out. The ethics committee responsible for the site where the trial is to take place also needs to give approval. 

TMF audits can be conducted at any stage of a clinical trial, for example before shipping investigational medicinal products (IMPs) to a clinical... 

Figure 34.4 Flowcharts for reportability assessment (a) assessment of expedited reportability (Europe) investigational medicinal products (IMPs) (b) assessment of reportability of individual case safety reports (ICSRs) in Europe post-marketing...

Good Manufacturing Practices (GMP) for study drugs and the provision for a manufacturing licence for investigational medicinal products (IMPs), and labelling requirements... 

Historically, in the UK and Europe, there has been no legal requirement to manufacture drag products or APIs to GMP for use in clinical trials (investigational medicinal products, IMPs). This has always been a requirement under the USA FD C Act. 

In the clinical phase of development of new chemical entities, medicines are developed by hospitals, xmiversities, or pharmaceutical companies and administered to humans as Investigational Medicinal Products (IMP) . In Europe, the administration of IMPs to human beings is regulated by Directive 2001/20/EC (which has been replaced on the... 

For all investigational medicinal products (IMPs) used in a clinical trial EU Directive 2001/20/EC ( CUnical Trial Directive ) and GMP Annex 13 are applicable [6, 7], see Sect. 35.5.10. The clinical trial directive has recently been replaced by the new and less stringent EU regulation 536/2014 [8,9]. In this regulation, GMP and a manufacturing license will no longer be required for the preparation of diagnostic radiopharmaceuticals used in clinical trials when they are prepared in a hospital radiophaimacy from licensed sources and used within the Member State. 

The final release of products comprises a major responsibility, which must be independent of production. In pharmaceutical industry release is performed by a qualified person (QP), in pharmacies often by a pharmacist. Investigational medicinal products (IMPs) always have to be released by a notified QP (Sect. 25.3.4). 

Investigational Medicinal Products (IMPs) are not medicines and the subjects are not patients. The purpose of IMPs is not to treat a disease but to experiment with a product to discover if it would treat a disease. 

The legislation on Investigational Medicinal Products (IMPs) is described in Volume 10 of the Rules [23]. It consists of six chapters, each containing several documents that are regularly updated ... 

ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use IEC Independent Ethics Committee IMP investigational medicinal product IND investigational new drug (USA)... 

EEA, European Economic Area GLP, good laboratory practice GMP, good manufacturing practice ICH, International Conference on Harmonisation IMP, investigational medicinal product SI, statutory instruments. 

GMP annex 13 Investigational Medicinal Products applies GMP to the manufacture of IMPs. Separate legislation for IMPs as compared with medicines warrant their specific position. The formulation of the product may change during the trial. Blinding is often required which introduces the risk of mix-up. The preparation or reconstitution process is not routine yet. Extra securities on the preparation are necessary not only to protect the subject, but also to prevent differences between batches or improperly documented batches. 

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