Registration, data requirements

European Commission, Residues Guidance for Generating and Reporting Methods of Analysis in Support of Pre-registration Data Requirements for Annex II (Part A, Section 4) and Annex III (Part A, Section 5) of Directive 91/414, SANCO/3029/99 rev. 4, 11.07.00. European Commission, Bmssels (2000). 

An example of the kinds of data required for land disposal options would be Information on soll/pestlclde Interactions to determine the effect of the pesticide on the soil and soil on the pesticide. The physical composition of the soil and the physical properties of the pesticide and Its formulation will determine the adsorption, leaching, water dispersal, and volatilization of the pesticide which. In turn, determine the mobility of the pesticide In soil. Even pesticides of closely related structures may have very different soil retention properties. Much of this data will be available from that developed to meet other registration data requirements with the exception that disposal rates are often orders of magnitude higher than normal application rates and the difference must be considered. 

A simplified set of registration data requirements would be demanded for safe or permissible uses14 using a basic tick box approach . Safe uses would not be subject to further risk management under REACH unless evidence indicated that registered data are incorrect. Permissible uses would not be prioritised for evaluations or other decision-making, and would be issued with time-limited exceptions during restriction and authorisation. 

FIFRA Sections 3 and 4 pertain to registration and reregistration of pesticides, with clearly defined data requirements as outlined in Tide 40 of the US. Code of federal Regulations (51). About 120 different studies are Hsted, most of which are to be done on technical-grade active ingredients (TGAIs). 

Japan. In Japan, registration of dmgs for aquatic species requires the same data as those required for dmgs on other animals. The Ministry of Agriculture, Eorests, and Eisheries and the Ministry of Welfare control the use of chemicals in aquaculture in Japan (17). The preclinical data requirements include product chemistry, toxicity (acute, subacute, special) using rats and mice, safety to target animals, and metaboHsm. The requirements for clinical data include avadabiHty and residues. As of July 1990, more chemicals were registered for aquacultural use in Japan than in any other country (Table 4). 

The majority of validation data required for analytical methods supporting authorization purposes are common to those described for enforcement methods (see Section 4). However, some of the requirements such as minimum cost and commonly available equipment do not apply to methods supporting pre-registration studies (e.g., the use of GC/MS/MS technology). 

The analytical methods for post-registration control and monitoring purposes submitted by industry to the authorization bodies help the enforcement laboratories. Data requirements from the authorization procedures are constantly compared with the needs of enforcement laboratories, in order to supply them with relevant data, and to avoid the generation of superfluous information. 

To commercialize agricultural end-use products in Japan, applicants are required to submit appropriate data to MAFF. The data required for registration are summarized in this section. 

Finally, to avoid the parallel use of similar but not identical method validation studies to fulfil the registration requirements, e.g., of the EU, US Environmental Protection Agency (EPA) or Japanese authorities, an adaptation of different data requirements for residue analytical methods for post-registration control and monitoring purposes would help to save resources. 

Finally there will be some very high concern chemicals for which uses have to be authorised. Many of these will already be known, because the CMR classifications are already established. Other substances for authorisation will be identified as the initial registration data are developed and collated, perhaps especially for those found to be classed as PBT or vPvB substances. Other new CMR substances requiring authorisation will emerge at the evaluation stage when the additional studies are undertaken. 

From a regulatory standpoint, it was emphasized that data to be used for registrational purposes require an audit trail back to the medical record, as is standard for all other data submitted for this purpose. Anonymous or anonymized data14 are not auditable and would not be appropriate for registrational use. 

This low ratio is partly due to the relatively high data requirements for registering new snbstances (with small tonnages) and also the relatively early point of registration in the innovation cycle (before technical trials with customers). 

In October of 1981, EPA decided to reorganize the guidelines and limit the regulation to a concise presentation of the data requirements and when they are required. Therefore, data requirements for pesticide registration pertaining to all former subparts of the guidelines are now specified In part 158 (40 FR 53192 November 24, 1982) which specifies the kinds of data and... 

U.S. Environmental Protection Agency, Pesticide Registration Proposed Data Requirements, Federal Register, Vol 47, No. 227, November 24, 1982. 

The data requirements for the registration of new drugs were defined in the Pharmaceutical Affairs Law and its Enforcement Regulations. Practical guidelines were issued in PMSB Director General Notification No. 481 dated... 

As previously mentioned, Australia has closely aligned its data requirements for the registration of prescription medicines with those of the European Union. The ARGPM describes certain... 

The registration of a drug starts with an application in which the sponsor includes all data required by the NRA for evaluating new animal drugs. An outline of the required data includes ... 

---