Registration in the USA

Department of Agriculture (USDA) in accordance with 9 CFR, parts 101-123 in subchapter E on serums, toxins and analogous products, organisms and vectors. 

Some guidance may be obtained from the official definitions According to 21 CFR 600.3 a biological product means ... any virus, therapeutic serum, toxin, antitoxin or analogous product... . Further explanations state that a product is analogous 

Hormones (and related molecules) are clearly regulated as drugs, and it appears that biological products are those which are made from the 

The matter is not yet resolved in a satisfying way. Further comittees discussed the separation of competences between the FDA and USDA, but a reasonable compromise could not yet be found. As long as these discrepancies exist, it will be necessary to discuss a product candidate 

Imports of biological products into the USA are restricted by the requirement to have the manufacturing facilities licenced and inspected by US inspectors or by local inspectors, if these are recognized by the USA. Furthermore, biological products are subject to a permit for each individual shipment, quarantine for the product and tests by the authorities before release. Veterinary biological product licences will not be issued for products from countries ...known to have exotic diseases, including but not limited to, foot and mouth disease, rinderpest, fowl pest (fowl plague), swine vesicular disease, Newcastle disease, and African swine fewer (9 CFR 104.2). 

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Food and Drug Administration (FDA) Guidance for industry notes on various aspects of pharmaceutical product development, registration in the USA and inspections Web site http //www.fda.gov/... 

Since 1994, the automotive industry in the USA and Europe has been operating quality system certification schemes that extended the requirements of ISO 9001, ISO 10011, and EN 45012. One of these schemes was addressed by my QS-9000 Quality S /stems Handbook, published in 1996. In the same year the automakers of the USA and Europe formed the International Automotive Task Force (lATF) which, in cooperation with the technical committee of the International Organization of Standardization (TO 176), produced ISO/TS 16949. Use of and registration to this new standard is currently voluntary. It is intended that following the first revision to incorporate ISO 9000 2000, the ISO/TS 16949 certification scheme will be mandated by all major vehicle manufacturers on their Tier 1 suppliers. As a result, the standard will be cascaded along the supply chain, ultimately reaching all suppliers to the global automotive industry. 

SAS/BASE is a registered trademark or trademark of SAS Institute Inc. in the USA and other countries. Indicates USA registration. 

Where a crop which constitutes a part of the US diet is not grown in sufficient quantity in the USA to warrant the cost to obtain a US registration, an import tolerance is required. Crops that are grown extensively in Latin America, such as coffee, banana. 

In addition to the processed commodities listed in the Series 860 Table 1, some registrants choose also to provide data on other processed fractions. With the advent of the Food Quality Protection Act of 1996 and the emphasis on protecting the food supply for children, collecting residue data on additional processed commodities may be prudent. Fruit purees are popular as baby food in the USA and are an example of a processed commodity that could come under additional scrutiny since they make up a large portion of an infant diet. 

Registration of a new chemical substance in the USA, Canada, Japan, Australia, Korea, China, or the Philippines requires similar comprehensive sets of data, although there are some differences. Obtaining all the data for a full registration can be time-consuming and costly. In 2000 it cost approximately 150 000 to 200 000 and took about two years to register a new substance in Europe. 

To provide a forum for a constructive dialogue between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the CEC, USA and Japan ... 

With whole-herd applications of antimicrobial and antiparasitic substances and live vaccines in mind, ecotoxicity assessments have been included in the registration reqirements for veterinary products in the EEC and the USA. A defined procedure exists in the USA where a "Finding of no significant impact" (FONSI) certificate by the Animal and Plant Health Inspection Service (APHIS) is a necessary prerequisite for the registration. 

Information Sources on Registration Requirements for Veterinary Medicinal Products in the USA... 

There are currently two approaches for setting REIs in the United States one might be considered the past approach and the other the future approach. In the first approach, the EPA s Worker Protection Standards establish interim REIs based only on acute toxicity without any consideration of the crop, the work activity or exposure. Recognizing that risk is a product of toxicity and exposure, this approach is limited in that it only takes into account one-half of the risk equation. Nonetheless, this approach is the basis for most of the REIs currently in place in the USA. In the second approach, the EPA s re-registration process (as outlined in the Worker Protection Standards) requires the development of product, crop and activity-specific REIs based on the risk associated with any given use scenario. The advantage of this approach is that it takes into account both the toxicity and exposure components of the risk equation. Such an approach is the... 

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