NATIONAL REGULATORY AUTHORITIES

In the past, a company wishing to gain a marketing licence within Europe usually applied for separate marketing authorizations on a country-by-country basis. This entailed significant duplication of effort as  

Attempts to harmonize European pharmaceutical laws were accelerated in the 1980s. From 1985 onwards, a substantial number of European pharmaceutical directives have been adopted. This entire legislation has been published in the form of a nine-volume series entitled The Rules Governing Medicinal Products in the European Union (Table 4.11). These volumes form the basis of EU-wide regulation of virtually every aspect of pharmaceutical activity. 

Attempts to harmonize European pharmaceutical laws were accelerated in the 1980s. From 1985 onwards, a substantial number of European pharmaceutical directives have been adopted. 

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Two rappoteurs are then appointed (committee members who are responsible for getting the application assessed). The rappoteurs generally arrange to have the application assessed by their respective home national regulatory authorities. Once assessment is complete, the reports are presented via the rappoteur to the CPMP. After discussion, the CPMP issue an opinion (i.e. a recommendation that the application be accepted, or not). This opinion is then forwarded to the European Commission, who have another 90 days to consider it. They usually accept the opinion... 

The mutual recognition procedure is an alternative means by which a marketing authorization may be sought. It is open to all drug types except products of biotechnology. Briefly, if this procedure is adopted by a sponsor, then the sponsor applies for a marketing licence not to the EMEA, but to a specific national regulatory authority (chosen by the sponsor). The national authority then has 210 days to assess the application. 

If national regulatory authorities can rely on safety test data developed abroad, duphcative testing can be avoided and costs saved to government and industry. Furthermore, a reduction in the number of laboratory animals used for testing of chemicals is an important goal in relation to animal welfare. 

In the pre-marketing phase of new drug development national regulatory authorities encourage and evaluate a broad range of experimental methods that come within the definition of clinical trials. 

Direct reporting of adverse drug reactions to national regulatory authorities has been possible... 

Table 2. Minimum regulatory functions for a national regulatory authority (NRA)...

The below definition needs some explanatory words (Box 5). A first aspect to consider is that counterfeiting implies the intention to cheat those who receive the medicine - either in the distribution chain or as patients. This is important because it permits to make necessary distinction between counterfeit medicines and sub-standard medicines. Counterfeit medicines are sub-standard because they are manufactured and distributed out of control and their composition is unpredictable. On the other hand, not all sub-standard medicines are counterfeits. Substandard products are genuine products, manufactured by officially licensed manufacturers, which do not meet quality specification set for them. All substandard products are manufactured without compliance with Good Manufacturing Practices (GMP) and other regulatory requirements established by the competent national regulatory authorities in order to ensure that efficacy and safety of medicines is not affected by quality problems. 

These organisations, and the relevant staff representatives, were identified from EU and national regulatory authority documentation, such as publicly available reports and consultations. 

Table 4.3 Principal roles and responsibilities of the national regulatory authorities...

AU this makes good business sense and should eliminate the need for corrective work because of misunderstood validation requirements. Similar harmonization would appear to be occurring on the topics of electronic records and electronic signatures. Mutual Recognition Agreements (MRAs) between various national regulatory authorities such as the FDA, MHRA, TGA, and MHLW and the work of the International Conference for Harmonization (ICH) offer an opportunity to formally consolidate harmonized computer validation requirements. 

Both ephedrine and pseudoephedrine remain worry-ingly popular (4) and are widely available without prescription. Based on increasing evidence of the risks of Ephedra self-medication, various national regulatory authorities are currently considering recalling Ephedra products from over-the-counter sales. Oral doses of ephedrine 25-30 mg are often prescribed, for example for orthostatic hypotension. Lower oral doses, present in some cold remedies in tablet form, are unlikely to be efficacious, although they are risky where the drug is... 

Overview of PharmaceuticcJ Regulatory Background National Regulatory Authorities Technical Division... 

In Switzerland health controls are largely a cantonal responsibility including healthcare systems, hospitals, professional education and the registration of medicines. In exceptional cases differences can exist, for instance, in the prescription status of individual pharmaceutical products from canton to canton (these are more the exception than the rule, however). To avoid duplication of effort and conflicting advice, the responsibility for pharmaceutical registration lies with the national regulatory authority, the Intercantonal Office for the Control of Medicaments (Interkantonale Kontrollstelle fiir Heilmittel or IKS). 

The national regulatory authority for Switzerland (and Liechtenstein) is the Interkantonal Kontrollstelle fiir Heilmittel (IKS), located in the federal capital Berne. The IKS can be reached as follows ... 

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