Registration and approval

The differences between a product for pain and a product for arthritis is measured in years and millions invested. If a company has many projects at an early stage of development it is clear that there will be a long time before these will generate income. However, a Tate stage compound in phase lib, where safety is being assessed, may still have several years of expensive clinical trials to complete before filing for registration and approval can be made. In... 

The Committee recommended that industry ensure that containers for public health pesticides meet the following design characteristics and satisfy the needs of national registration and approval systems. 

The goal of these plans is to provide a lean, efficient NDA/BLA/MAA with the minimum studies needed for registration and approval in the world markets. The medical, scientific, regulatory and marketing opinions must be weighed and balanced in the plans. 

Clinical trials aimed at securing registration and approval for a new treatment are often biased toward assessing the safety of the treatment we need, however, to bear in mind that risks are associated with the disease as well as with the treatment, and that a more clinically relevant index than treatment toxicity is the disease risk-treatment risk ratio. 

China. Japan remains focused on possible genetic differences, and continues to insist upon studies conducted in its own population as a condition for registration and approval. Regional variations, such as diet, alcohol and tobacco consumption, climate, exposure to pollution and other environmental factors, socioeconomic status, and differences in technology and health care standards, require creative planning for multinational trials. 

The registration and approval situation in Japan is different from that of the USA and the European countries. In Japan, no official statements have been issued on the regulation of chiral dmgs [12, 19]. However, the Japanese registration authorities recommend adherence to the guidelines adopted in other countries. The Japanese authorities also recommend investigations into the absorption, distribution, metabolism and excretion of each of the enantiomers of a particular dmg. 

Registration and approval by Gosstandart prior to sale is compulsory for cosmetics. First a hygiene certificate must be released by RosPotrebNadzor (formerly known as GosSanEpidNadzor—Russian Committee for Sanitary and Epidemiological Surveillance), which will allow a Certificate of Compliance to be issued by Gosstandart. This process. 

U.S. Environmental Protection Agency (USEPA). 1976a. M-44 sodium cyanide capsules. Approval of registration for use in device to control predators and waiver of data in support of registration and classification. Fed. Regis. 41(39) 8415-8416. 

Complying with such requirements can lead to drastic reduction of the availability and to long delays in obtaining the approval for registration and industrial production. 

Concordance would facilitate international commerce in official articles by allowing the reduction of duplicate testing or delay in national product registration or approval proceedings. No provision of the USP General Notices is abrogated and the allowance therein for alternative methods is not foreclosed by a monograph citation to the concordance. 

Most biocide products continue to be sold under some form of brand name, which often does not properly describe the active materials contained (although the precise active chemicals are normally listed in the health and safety sheets). However, increasingly around the world, it is becoming necessary to provide all relevant information on the product label, in an approved manner, and for the company whose name appears on the label to be properly subregistered with the relevant authorities. (This has been required in the United States for many years.) This original registration and... 

Aldrin and dieldrin have never been produced industrially in China but were produced on a pilot scale for termite control. Endrin has never been produced in China. Both aldrin and dieldrin are agricultural pesticides, which can prevent the damage caused by soil insects, such as termites, locusts, moths in wood, etc. However, the Ministry of Agriculture has never approved the registration and use of aldrin and dieldrin as agricultural pesticides. The application of dieldrin was concentrated in... 

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