Marketing authorisations safety

An Investigational Medicinal Product Dossier (IMPD) is intended to be more comprehensive than an IB, in that it should contain summaries of available quality data in addition to the safety and efficacy information that constitutes the main part of the IB. In total, it should provide information on the chemistry, manufacture, control and stability ofthe medicinal product, together with the results of non-clinical and clinical studies. In order to avoid repetition, the IB can be cross-referenced for non-clinical and clinical results. Ideally, the IMPD should follow the same structure as that which will be used later for the marketing authorisation application. For products with existing marketing authorisations, the Summary of Product Characteristics may replace the IMPD to varying extents (see Chapter 6). 

Recently, similar legislation has been introduced in the European Union under regulations EC/1901/2006 and EC1902/2006. This requires that marketing authorisation applications for new drugs submitted after the 28 July 2008 must be accompanied by either the results of specific studies demonstrating safety and... 

Marketing authorisation holders are obliged to submit Periodic Safety Update Reports (PSURs) according to the frequencies outlined as follows ... 

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). 

In the European Union there have been several petitions to approve stevia and its products. In 2000, the EU Commission refused marketing authorisation for Stevia rebaudiana Bertoni plants and dried leaves as a novel food or novel food ingredient (Official Journal of the European Communities, 2000). In October 2003, the SCF rejected a request to re-examine the restrictions on the uses of extracts of stevia. Its comment, after throroughly examining the evidence, was that the committee has serious doubts about the safety of stevioside and does not consider it acceptable for use in food (European Parliament, 2003). 

Regulation 2377/90 contains the following four annexes in which the substances are listed after evaluation I. Substances for which final MRLs have been fixed II. Substances for which MRLs are not deemed necessary in order to protect public health III. Substances with provisional MRLs - if a dossier is incomplete, the manufacturer may be given a set time (up to five years) in which to provide the necessary information IV. Substances for which it is not possible, due to safety concerns, to set an MRL - the administration of substances listed in this annex is prohibited throughout the EU and the marketing authorisation for the medicines concerned has been withdrawn. 

They need assurance that the medicines they are offered fulfil these requirements and are supported by information that permits optimal use. The information about and the usage of medicines gets out of date, and there is an obligation on licence holders continually to review their licence with particular regard to safety. Marketing Authorisation Holders (MAH), i.e. pharmaceutical companies, can also change the efficacy claims to their licence, e.g. new indications, extension of age groups, or... 

They must concern regulatory approved products used in approved indications and can include, but not only, non-interventional trials, observational trials, post-marketing surveillance and post-authorisation safety studies. 

Data on safety, efficacy and other important clinical results with respect to marketed products must be truthfully published on the internet, irrespective of the outcome of the trial within the year after the marketing authorisation has been granted. 

All Member States of the European Community were similarly required to review the quality, safety and efficacy data of products on their markets. Various dates were set for the completion of such national reviews, and the schedule had to be revised on a number of occasions because of slow progress in some Member States. The various national review processes have not led to harmonised terms of the marketing authorisations for these older products within Europe. 

Once the clinical and safely evaluation studies for a new medicinal product have shown it to be safe, effective and of acceptable quality, the pharmaceutical company will usually want to submit a Marketing Authorisation Application (MAA) or New Drug Application (NDA) to the regulatory authorities. The chemistry, manufacturing and controls (CMC) section will form a major part of the application. For an MAA in Europe, a development pharmaceutics section is required to describe how the product was developed, and to explain the rationale for the selection of the formulation, pack, manufacturing process and specifications. Also required for Europe are expert reports for each of the pharmaceutical, safety and clinical parts of the application. These have to be written by experienced scientists nominated by the pharmaceutical company who have to critically appraise the development programme for the product. The pharmaceutical expert must acknowledge the acceptability of the CMC part of the application. 

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