Registration authorities

The 1981 Council Decision (OECD 1981) sets the policy context agreed by aU OECD Member countries which estabhshed that safety data developed in one Member country will be accepted for use by the relevant registration authorities in assessing the chemical or product in another OECD country, i.e., the data do not have to be generated a second time for the purposes of safety assessment. 

This high attrition rate, particularly during late preclinical and clinical development, carries a large price tag for the pharmaceutical and biotechnology industry, which is carried over to health care providers. In addition, compounds which qualify for clinical use but fail due to safety matters raise serious ethical issues and questions concerning the responsibility and competence of the industry and registration authorities. 

Anonymous, Report of the Working Party on Residues of Long Acting Antibiotics at Injection Sites. National Registration Authority, Camberra, Australia (1995). 

An additional factor in the high level of noncompliance is that the Australian MRLs in offal (0.05 mg/kg for chlortetracycline and 0.25 mg/kg for oxytetracycline) are significantly lower than those now recommended by Codex Ali-mentarius (0.60 mg/kg for both compounds). Thus, the registration data, withdrawal periods, and MRLs for these compounds are currently being reviewed by the responsible bodies in Australia, namely the National Registration Authority and the Australia New Zealand Food Authority. 

APVMA (formerly the National Registrations Authority for Agricultural and Veterinary Chemicals) (November 1997). The NRA review of atrazine. 

National Registration Authority for Agriculture and Veterinary Chemicals of Australia (November 1999). The NRA review of atrazine existing chemical review program. 

In conclusion, all the new systemic fungicides against Oomycetes had an immediate need for mixing partners. It can be assumed that this will also hold true for future systemic fungicides. This use concept calls for flexibility both on the part of industry, national registration authorities, and the extension services to make safe and powerful products available for plant protection. 

In August 1992, the Commonwealth announced that it would establish a National Registration Authority for Agricultural and Veterinary Chemicals (NRA) to undertake registration activities, with associated policy issues being the responsibility of the Department of Primary Industries and Energy. 

Information on agricultural practices that may impact on drinking-water may be obtained from direct surveys of catchments and from a variety of other sources, such as farmers associations, agricultural authorities or university extension services. Information on pesticide use may be available from these sources but, in many countries, registration authorities are the most important source of information. Where pesticides are imported, customs authorities may also be able to provide valuable advice. The department of agriculture or farming organizations may know which pesticides are used in a particular catchment. Information on production of pesticides for local markets may be available from departments of industry, chambers of commerce, industry associations and similar bodies. 

WHOPES functions in close collaboration with national disease and pest control programmes and national pesticide registration authorities, many international and regional organizations and institutions concerned with pesticide management, legislation and regulation, research institutions and with industry. 

Guideline specifications for household insecticide products — mosquito coils, vaporizing mats, liquid vaporizers and aerosols, were drafted at a WHO informal consultation, held in Geneva from 3 to 6 February 1998 (6). The draft guidelines have been distributed to ministries of health and national registration authorities for comments and suggestions. 

For example, the chosen expression system for the active component or the crucial adjuvant component of a vaccine could be unacceptable for registration authorities. This would require the development of another system and the repetition of all critical experiments. One might also find out that the efficacy of the product in mind cannot compete with already existing therapies. 

Analytical methods are validated by investigating the specificity, sensitivity, detection limits, quantification limits, accuracy (of the individual result), precision (variation between different tests), applicability and practicability under laboratory conditions and the robustness (susceptibility to interference) of the method. This enables the organization itself to employ these tests much more consciously and with better results, but it also serves the purpose of enabling the registration authorities to use these tests for the regular batch control tests. Official guidelines by the regulatory authorities for the validation of analytical methods and processes are available for consultation. 

A central EEC registration authority (European Agency for the Evaluation of Medicinal Products) will be established and "shall take up its responsibilities on 1 January 1995 (Council Directive 2309/93 of 22 July 1993). The Committee on Proprietary Medicinal Products, CPMP, which consists of members of the Commission and from the states authorities, plays a central role in the existing and future system. It is assisted by different working parties for specific areas. The CPMP coordinates the procedures, assesses applications and provides "opinion reports" and acts as arbitrator in the case of national discrepancies. However, the opinion reports and decisions of the CPMP are not (yet) binding to the member states. For veterinary products identical rules apply here a CVMP acts as the central body. 

Besides the formalised contacts within the Benelux and the EU, there are also good informal contacts with other registration authorities, in particular with the Scandinavian countries and the United Kingdom. Furthermore, there are informal contacts with the World Health Organisation (WHO) in Geneva and Copenhagen. 

An application for registration of a pharmaceutical specialty shall be made by the manufacturer. A foreign manufacturer shall be represented in Slovakia by a domiciled agent (representative) who is empowered to plead the manufacturer s application before the State Institute for Drug Control. Correspondence between the registration authority and the foreign manufacturer usually should be forwarded via the agent. 

Except for the cases discussed in section 4, these guidelines recommend that documentation of equivalence with the comparator product be required by registration authorities for a multisource pharmaceutical product. Studies must be carried out using the product intended for marketing (see also section 6.5). 

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