National Competent Authorities

Executive responsibility for the administration of regulations at national level is divested in dedicated agencies. Although distinct from government departments, the Ministers of Health are the usual political masters of these national Competent Authorities. Eor example, the authority in Ireland is known as the Irish Medicines Board (IMB) and it covers both drugs and devices. Similar to the EMEA, the authorities are scientific and technical in orientation and are guided by various advisory panels. Their main tasks include ... 

National Competent Authorities are primarily responsible for managing responses to pharmacovigilance issues on their territory. However, the reference Member State is... 

Incidence reference number and name of the co-ordinating national competent authority (if appticabie)... 

Identify to vrfiat other national competent authorities this report was also sent... 

Exactly how inspection is to be done is not clear. Whereas there was some good collaboration and an effort in the early days within IFOAM, the inspection bodies now focus on what their national competent authority requires. The result is that inspection regimes in the various EU member states vary, although the extent of this variation is not known. 

The information included in the registration of the ca 5,000 substances exceeding a production or import volume of 100 tonnes per annum will have to be evaluated . The proposed Regulation foresees that national Competent Authorities will act on behalf of the ECA to do this work. 

The applications for national authorisations are submitted to the national competent authority which, in the United Kingdom, is the Licensing Authority (LA), whose functions are discharged by the Medicines and Healthcare products Regulatory Agency (MHRA, previously Medicines Control Agency, MCA) of the Department of Health. The LA/MHRA are advised by the CSM, a multidisciplinary scientific body consisting of clinical, preclinical and pharmaceutical members well known for their expertise in their respective fields. Lay members are also included. 

At the time of receipt of the letter of intent, the proposed invented (trade) name will be checked. Elowever, review of the trade name more than 6 months in advance of the submission date is also acceptable, although such an early checking will only serve to detect objections that exist at that time and not later. This check is performed by the EMEA in liaison with the national competent authorities, in order to determine whether the name would raise any identifiable public health concern, for resolution 1 month thereafter. 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

This guideline lays down the requirements and procedures for national competent authorities regarding the collection, evaluation and management of pharmacovigilance data on medicinal products, however authorised in the community. 

Essentially, four major activities still remain entirely within the remit of national competent authorities. 

The best demonstration of success for the GHTF will be the incorporation of the GHTF-endorsed harmonized requirements into existing regulatory systems by the various national competent authorities. 

European Medicines Agency and National Competent Authorities 72... 

Dejas-Eckertz P, Shaffner G. Scientific advice by the nationally competent authority and the EMEA on the conduct of clinical trials. Bundesgesundheitsblatt Gesund-heitsforschung Gesundheitsschutz 2005 48 423-8. 

When working for the EMEA, members of the CPMP and CVMP act independently of their nominating member state. The scientific committees are aided by a network of approximately 2300 European experts, nominated by the national competent authorities of the member states on the basis of proven experience in the assessment of medicinal products. Experts may serve on working parties or expert groups of the CPMP or CVMP. 

The scientific committee decides the appointment of rapporteurs and corapporteurs, i.e., those members of the CPMP or CVMP who take the lead in reviewing a dossier. The committees are required to ensure that all members undertake the role of rapporteur or corapporteur. Compensation is provided to national competent authorities for the services provided by committee members or European experts at the specific request of the agency. 

Non-promotional information for patients and the general public Subject to any applicable national laws and regulations, websites may include non-promotional information for patients and the general public on products distributed by the company (including information on their indications, side effects, interactions with other medicines, proper use, reports of clinical research, etc.), provided that such information is balanced, accurate and consistent with the approved summary of product characteristics (SPC). For each product that is discussed, the website must contain full, unedited copies of the current SPC and patient leaflet. These documents should be posted in conjunction with other information about the products or be connected with that discussion by a prominent link advising the reader to consult them. In addition, the website may provide a link to the full, unedited copy of any public assessment report issued by the Committee for Medicinal Products for Human Use or a relevant national competent authority. Brand names should be accompanied by recommended international non-proprietary names (rINNs). 

The National Competent Authority and ethics committee initially validate the application and the sponsor is informed that the application is valid (i.e. the format is appropriate and that the application appears prima facie to be complete and accurate). Ethics committees have the same review clock as regulatory authorities, including the special situations with extended or eliminated timeframes (see... 

Clinical trial authorization (CTA) by national competent authorities... 

Scientific advice is provided by regulatory authorities so that sponsors can design drug development plans that eventually are likely to satisfy the reviewers for MA. The individual national competent authorities offer scientific advice, on written request, and does the EMEA through the CHMP. 

At the national level within Europe, the situation becomes yet more complicated for both regulatory and less tangible, cultural reasons. Each member state has a National Competent Authority (NCA) regulating pharmaceutical product price, label and distribution. Each NCA can mandate product withdrawal within its boundaries, and notify others about its concerns. But such a decision is never binding in any other part of the EEA, and there is certainly no obligation for one member state to implement a risk management program that has been mandated at the national level elsewhere. 

Examples of International disharmony. The examples of diacetylmorphine and thalidomide (see above) are examples of pharmaceutical products that are available either only in Europe or only in the United States, respectively. Within Europe, the existence of National Competent Authorities provides further scope for nonuniform risk management plans. 

A product that has been formally submitted for registration by a manufacturer to a national competent authority and which has been rejected on grounds of safety. 

According to this draft Commission Directive, the laboratories may choose any analytical method for the purpose of monitoring under Article 8 and Annex V of Directive 2000/60/EC provided they meet the minimum performance criteria set out in this document or by the national competent authorities. 

The same GMP guidelines are, where relevant, valid for the preparation of radiopharmaceuticals in hospitals. Some national competent authorities have issued detailed regulations about what has to be considered. Detailed requirements such as ... 

Substances supplied at <10 kg a are exempt from notification, but individual Member States may choose to require appropriate technical and commercial data to be submitted. Substances supplied at <100 kg a for scientific research and development are exempt from notification, but records of supply to customers must be available for inspection by the national Competent Authority. Substances can be supplied for process-orientated research and development to a limited number of registoed customers without tonnage limit for up to 1 year (extended to 2 years if justifiable). Individual Member States can decide what information is required, up to the maximum requirement for limited notification . If substances supplied under these three exemption categories are provisionally classified as very toxic , toxic , carcinogenic , toxic for reproduction or... 

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