National Production Authority

In programming chemical expansion and in studying supplies and requirements of chemicals, statistics are essential. Production statistics are obtainable through federal agencies, but data on plant capacities, uses, and raw material requirements are also necessary. Such data were developed by the Chemical Division of the National Production Authority on officially approved forms, which were sent to chemical producers. By the end of 1951,92 specific chemicals were surveyed, analysis of data is in progress regularly, and results of such analyses are put to immediate use by the various chemical specialists. 

One of the most important of these and the one which controlled chemicals, was the National Production Authority (NPA) set up within the Department of Commerce. NPA had 33 divisions, including the Chemical Division. The nucleus of this unit was personnel from Office of Domestic Commerce s Chemical Division. 

Certain international organizations and United States agencies with international programs prepare summaries and compilations, essentially of the data taken from the national official publications. The principal source of such information, specifically on chemicals in foreign nations, was for a number of years and until the end of 1950 the Office of International Trade of the Bureau of Foreign and Domestic Commerce since the beginning of 1951 the major part of the program of commodities information has been in the National Production Authority. 

U. S. Department of Commerce, National Production Authority, NPA Product Assignment... 

An excellent paper on sources of government statistics on chemicals (S9) was presented recently at an American Chemical Society meeting by Miss Margaret Donnelly, formerly of the National Production Authority of the Department of Commerce. Reprints of this paper are available from NPA. 

National Production Authority, Chemical Division, Government Production Statistics as... 

National Production Authority, Defense Production Record, weekly. May 3, 1951-Jan. 1, 1953. Summarizes activities of Defense Production Administration and related federal agencies. Includes certificates of necessity issued by D.P.A. for rapid amortization of new chemical facilities. 

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. 

The information included in the registration of the ca 5,000 substances exceeding a production or import volume of 100 tonnes per annum will have to be evaluated . The proposed Regulation foresees that national Competent Authorities will act on behalf of the ECA to do this work. 

Similarly, where there are public health concerns as a result of pharmacovigilance data, nationally authorized products or products authorized by the mutual recognition procedure may be referred rmder Articles 12 or 15 of Directive 75/319/EEC. The CPMP/CVMP gives an opinion on variation, suspension, or withdrawal of the marketing authorization in such cases. 

The applications for national authorisations are submitted to the national competent authority which, in the United Kingdom, is the Licensing Authority (LA), whose functions are discharged by the Medicines and Healthcare products Regulatory Agency (MHRA, previously Medicines Control Agency, MCA) of the Department of Health. The LA/MHRA are advised by the CSM, a multidisciplinary scientific body consisting of clinical, preclinical and pharmaceutical members well known for their expertise in their respective fields. Lay members are also included. 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

This guideline lays down the requirements and procedures for national competent authorities regarding the collection, evaluation and management of pharmacovigilance data on medicinal products, however authorised in the community. 

Government development and production of vaccines has been proposed in a bill before Gongress H.R. 4100, the National Vaccine Authority Act. The National Vaccine Authority would be established by the U.S. Department of Health and Human Services and would engage in research, development, and production of vaccines to protect civilians against bioterrorist attacks and other limited use vaccines, such as those that would protect travelers going to disease-endemic countries. The National Vaccine Authority would oversee a government-owned laboratory that would be operated by a private contractor to produce vaccines the private sector does not supply at current prices. 

In 1993 the Institute of Medicine Gouncil proposed the establishment of a National Vaccine Authority because the private sector alone cannot sustain the costs and risks associated with the development of most Ghil-dren s Vaccine Initiative vaccines, and because the successful development of vaccines requires an integrated process, the committee recommends that an entity, tentatively called the National Vaccine Authority, be organized to advance the development, production, and procurement of new and improved vaccines of limited commercial potential but of global public health need (Mitchell, Philipose, and Sanford 1993). But in its recent report. Strengthening the Supply of Routinely Recommended Vaccines in the United States, the Center for Disease Control s National Vaccine Advisory Committee expressed little sentiment for the establishment of a National Vaccine Authority. 

The below definition needs some explanatory words (Box 5). A first aspect to consider is that counterfeiting implies the intention to cheat those who receive the medicine - either in the distribution chain or as patients. This is important because it permits to make necessary distinction between counterfeit medicines and sub-standard medicines. Counterfeit medicines are sub-standard because they are manufactured and distributed out of control and their composition is unpredictable. On the other hand, not all sub-standard medicines are counterfeits. Substandard products are genuine products, manufactured by officially licensed manufacturers, which do not meet quality specification set for them. All substandard products are manufactured without compliance with Good Manufacturing Practices (GMP) and other regulatory requirements established by the competent national regulatory authorities in order to ensure that efficacy and safety of medicines is not affected by quality problems. 

Bjarnason, J. O. Arnorsson, S. 1986. Nisyros Geothermal Development. Nisyros Well NIS-2. Production Characteristics and Fluid Composition. Unpublished National Energy Authority Report OS-86038, Reykjavik, Iceland, 97 pp. (In Icelandic.)... 

Thorhallsson, S., Armannsson, H. Hauksson, T. 1984. Milos Geothermal Development. Milos M-2 Production Test. National Energy Authority Report, December 1984, 93 pp. 

The industrial base of the vaccine industry presents challenges to DoD acquisition. The absence of a vaccine production capability adequate for meeting national needs is one reason, in 2001, the Institute of Medicine called for a national vaccine authority and the Gilmore Commission recommended creation of a government-owned, contractor-operated vaccine corporation. 

The amount and level of contaminants or impurities in water for pharmaceutical purpose depend on its use. Since water is used in all industries and scientific work, international and national standard authorities have established water quality parameters for all types of applications. Health-related water standards are given by organizations such as the World Health Organization (WHO) [2], the Environmental Protection Agency (EPA) [3], and the American Society for Testing and Materials Standards (ASTM) [4] in the United States and by pharmacopeial compendia when the aim is specifically related to water for pharmaceutical products for human and veterinary consumption. 

Hypoalgesia ICH (International Conference on Harmonization) Diminished sensitivity to a noxious stimulation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to harmonise scientific and technical aspects of product registration. They make recommendations which will be adopted by the national / EU authorities after an approval process. 

The interchangeability of conical joints (cone and socket joints) is ensured by the use of a standard taper of 1 in 10 on the diameter in accordance with the recommendations of the International Organisation for Standardisation and of the various national standardising authorities. The brand name Quickfit is a registered trademark (J. Bibby Science Products Ltd) and used to describe... 

---