Marketing authorisation assessment

In Europe, a sponsor may request an accelerated review of a marketing authorisation by the EMEA on grounds that the product is of major interest to public health, particularly from the viewpoint of therapeutic innovation. If granted, an accelerated review must be conducted within 150 days as opposed to the 210 days allowed for a standard technical assessment. 

Articles 21(3) and 21(4) oblige the competent authorities to make publicly available without delay the marketing authorisation, SPC, Assessment Report and reasons for the opinion after deletion of commercially confidential information. 

The full data package was submitted and assessed by assessors from each of the three disciplines. The Committee on Safety of Medicines and its sub-committees then considered their assessment report. If the decision was positive then a certificate was issued. If the decision was negative, then the applicant had the same appeal rights as those that apply to a marketing authorisation application (see Section 17.8.1). 

This procedure applies when a medicinal product has been granted a marketing authorisation by one of the Member States or when the same medicinal product is being examined by more than one Member States. Where a Member State notes that another application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 27 to 39 apply. 

Information on the centralised procedure can be accessed from the EC website (see end of chapter). The EMEA is required to ensure that the opinion of CHMP is given within 210 days after the receipt of a valid application. When an application is submitted for a marketing authorisation in respect of medicinal products for human use which are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation, the applicant may request an accelerated assessment procedure. If the applicant duly substantiates the request and if the CHMP accepts... 

On receipt of a valid application via the EMEA, the rapporteur and the co-rapporteur both prepare their separate detailed assessment reports, which are circulated to the EMEA and all other Member States by day 70 from the start of the procedure. The new Regulation requires that the duration of the analysis of the scientific data in the file concerning the application for marketing authorisation must be at least 80 days, except in cases where the rapporteur and co-rapporteur declare that they have completed their assessment before that time. 

Where an applicant wishes to market a product in more than one Member State, an identical dossier will be sent to all relevant Member States. If an authorisation has not been previously granted, one Member State will be appointed by the applicant to act as RMS who will prepare a draft assessment report with a draft SPC and a draft of the labelling and package leaflet. The CMSs will have the opportunity to review and approve the documents. Therefore, conceptually, the decentralised procedure resembles the centralised procedure without the involvement of CHMP, representing consultation between the Member States before even the first marketing authorisation is granted. 

Central to the decision to grant a marketing authorisation is the assessment procedure undertaken by professional medical, scientific, statistical and pharmaceutical staff at one of the national agencies. In the UK these are employed as dvil servants within the MCA and are advised by various independent expert committees (see above). 

Pharmacovigilance is about the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (see Sect. 35.4.2). The Marketing Authorisation Holder of a product has to have at his disposal a qualified person who is responsible for the pharmacovigilance of that product, the Qualified Person for Pharmacovigilance (QPPV) [3]. 

Parametric release of products with a market authorisation has to be authorised by the competent authorities. Authorisation is based on a strict set of requirements described in annex 17 of the EU GMP [7]. The principle of parametric release is also used in the release of terminally sterilised products in hospital pharmacy (see Sect. 30.9). The requirements mentioned in GMP annex 17 have to be described in a procedure. One of the requirements is a risk assessment of the process (see box in Sect. 34.14.1). 

For the application for a marketing authorisation clinical trials have to be performed. An official European body, the European Medicines Agency (EMA), assesses the therapeutic benefit risk ratio. 

Toxicity studies are expected to be performed in compliance with Good Laboratory Practice (GLP) however, it is recognised that some studies employing specialised test systems which are often needed for biopharmaceuticals, may not be able to comply fully with GLP. Areas of non-compUance should be identified and their significance evaluated relative to the overall safety assessment. In some cases, lack of full GLP compliance does not necessarily mean that the data from these studies cannot be used to support clinical trials and marketing authorisations. 

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

Before a device can be legally placed on the market in Europe, it must go through an appropriate conformity assessment process to establish that it meets all the essential requirements of the applicable directive. This enables the manufacturer to make a formal declaration of conformity and apply the CE mark of conformity to the device. The manufacturer, or an authorised representative (EC Rep), who takes on the responsibilities imposed by the directives on behalf of the manufacturer, must be established in the EU. 

Questions raised relating to the assessment of a marketing application e.g. Pre-authorisation Inspections... 

Cefic claims that polymeric materials, reaction intermediates and substances used for R D should not be subject to the REACH evaluation and authorisation process being proposed by the European Commission in its White Paper on future chemicals policy, it is briefly reported. On specific issues, Cefic wants a risk-based approach to chemicals assessment and regulation realistic deadlines for the REACH process and exemption from REACH of finished articles, so that it applies only to substances marketed as substances or as constituents of a preparation. 

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