Regulation data requirements

In an apparent deviation from this general principle, namely that efficacy studies are not required to be conducted under GLP conditions, the US EPA regulations state, that certain efficacy studies on pesticides have to be conducted under GLP, namely when they are considered as required studies by the relevant US Federal Regulations (Data Requirements for Registration, 40 GFR 158). The EPA GLP regulation 40 GFR 160 dealing with pesticides... 

Code of Federal Regulations, Data Requirements for the Registration of Pesticides, 40CFR, Parts 152, 153, 156, 158, 162 and 163, U.S. Government Printing Office. 

USEPA] US Environmental Protection Agency. 2007a. Data requirements for pesticide registration. Available from http //www.epa.gov/opp00001/regulating/data requirements. htm. 

New regulations to protect the applicant of the plant protection products were brought into force, regulating data requirements, experimental details for the measurement and model calculations [47, 48]. 

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). 

FDA device regulation is focused on the device and the device manufacturer. CLIA, on the other hand, focuses on laboratory quality, including the quality of the laboratory test results provided by the devices used, whether developed in-house or as a test kit in commercial distribution to multiple laboratories. The programs differ substantially in approaches and in data requirements. FDA requires unique submissions for each test under its purview, evaluates both performance and labeling, and requires demonstration of analytical validity and clinical validity as appropriate. CLIA inspects laboratories using a system approach based on key probes of the operating system. CLIA requires a demonstration of analytical performance and quality control but does not require a showing of either clinical validity or clinical utility. 

Except for the GB and HD test campaigns, for which the data were incomplete, the stack offgas did meet hazardous waste combustion and thermal treatment regulations and requirements criteria for waste streams. 

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... 

The data required for the risk assessment in relation to human health can be categorized as data on the identity of the substance, its physico-chemical and toxicological properties, and on exposure. The minimum data set required for a risk assessment depends on the chemical use category (industrial chemical, pesticide, biocide, food additive, food contact material, etc.), the regulation involved, and the goal of the risk assessment. This chapter will focus on the data used in the hazard assessment. 

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... 

The review regulation also requires that co-notifiers for the same active substance shall undertake all reasonable efforts to present a common notification, in whole or in part, in order to minimise animal testing for Annex 1 assessment. Unfortunately, this request for industrial collaboration must also be considered within the context that the specific provisions proposed to be developed by the Commission are not yet known and that the current status of data protection and confidentiality within the directive does not really encourage either investment or collaboration. 

The evaluation component of a QMS is intended to provide objective information and data that allow the organization to assess the conformity of the product, evaluate the performance of its quality system, and maintain and improve its effectiveness [10]. The cGMP regulations similarly require evaluation activities as shown in Table 4. 

Assessments of risks are, of course, only as good as the information on which they are based. For new substances, information had to be supplied before a chemical could be marketed. This was not the case for existing substances. Under the Existing Substances Regulation (Regulation (EEC) 793/93) manufacturers or importers of more than 10 tonnes per year of a substance listed in the inventory had to supply information on that substance to the European Commission, and as the amount they manufacture or import increased so did the data requirements. Manufacturers and importers had to make all reasonable efforts to obtain data... 

A protocol provides a mechanism for review of data and reports during, and at the conclusion of, the study. A regular review of the actual study conduct, 1n reference to the planned conduct as detailed 1n the protocol, provides a degree of confidence that the results obtained will be consistent with the study objectives. That 1s not to say that minor deviations can not, or should not, occur throughout the course of the study. The GLP regulations, however, require that these deviations be noted 1n the final report of the study. The study protocol provides the master" reference for compilation of these deviations. 

---