Regulatory authorities applications

At the time the application is submitted to the regulatory authorities, applicants should have validated the analytical procedures used in the specifications in... 

Do employee exposures to hazardous agents exceed applicable occupational exposure limits, including those of the ACGIH and the applicable local regulatory authority If yes, explain. 

Notification by sponsor and/or investigator, where applicable to regulatory authorities and IRBs/IECs of unexpected serious adverse drug reactions and other safety information... 

Final report by investigator to IRB/IEC where required, and where applicable, to the regulatory authorities... 

It should be noted that all technical data submitted in support of marketing authorisations remain confidential between the applicant and the regulatory authorities. In situations where the manufacturer of a drug substance is a different commercial entity to the applicant seeking approval of a drug product incorporating... 

Figure 8.5 shows the number of applications per staff member (professional plus administrative staff) and the number of applications per professional staff member. The workload per person related to registration varies greatly among the dmg regulatory authorities. Cypms has the largest load per individual professional staff member, and ranks second in workload per staff member of any grade. 

Accurate and even application of test substance is absolutely critical to study success. If the application is highly variable or deviates significantly from the target application rate, the study results may be technically unusable and/or unacceptable to regulatory authorities. Accurate agrochemical application begins with careful calibration of the spray equipment. Hence Study Directors should be familiar with sprayer calibration techniques, even if they will not be personally making the applications. 

In this chapter, the regulatory requirements relating to data on development pharmaceutics and process validation will be discussed. The discussion will be limited to Marketing Authorization Applications (MAAs) for the European Economic Area and many central and eastern European countries. 

Analytical chemistry is a critical component of worker safety, re-entry, and other related studies intended to assess the risk to humans during and subsequent to pesticide applications. The analytical aspect takes on added significance when such studies are intended for submission to the U.S. Environmental Protection Agency and/or other regulatory authorities and are thus required to be conducted according to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Good Laboratory Practice (GLP) Standards, or their equivalent. This presentation will address test, control, and reference substance characterization, use-dilution (tank mix) verification, and specimen (exposure matrix sample) analyses from the perspective of GLP Standards requirements. 

Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers submitted to support marketing authorization applications under the centralized procedure. Instead (as discussed in detail below), they forward the dossier to selected national EU regulatory bodies, who undertake the appraisal, and the EMEA makes a recommendation to approve (or not) the application based upon the national body s report. The overall role of the EMEA is thus to coordinate and manage the new system. The EMEA s annual budget is of the order of 120 million. The key objectives of the EMEA may be summarized as ... 

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. 

Land application of wastes is becoming more widespread as regulatory authorities move to protect water quality by restricting waste disposal into rivers, lakes and the marine environment. It is not clear, however, that soil is in fact an appropriate dumping ground for all our wastes. 

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