Pharmaceuticals administration

Nasal Administration. A route that has gained increasing popularity of late for pharmaceutical administration in humans is the intranasal route. The reasons for this popularity are the ease of use (and, therefore, ready patient acceptance and high compliance rate), the high degree and rate of absorption of many substances (reportedly for most substances up to 1000 molecular weight McMartin et al., 1987), and the avoidance of the highly acid environment in the stomach and first-pass metabolism in the liver (particularly important for some of the newer peptide moieties) (Attman and Dittmer, 1971). The only special safety concerns are the potential for irritation of the mucous membrane and the rapid distribution of administered materials to the CNS. 

Pharmaceutical Administration and Regulations in Japan website (March 2007), http //www.nihs.go.jp/pmdec/youkoso.htm [accessed August 24, 2007]. 

Pharmaceutical Administration and Regulation in Japan, March 2004, Japan Pharmaceutical Manufacturers Association. Available at http / /www.jpma. or.jp / 12enghsh / parj / index.html. 

Alekha K. Dash Department of Pharmaceutical Administrative Sciences, School of Pharmacy and Allied Health Professions, Creighton University, Omaha, NE 68178, USA... 

Anonymous Pharmaceutical Administration and Regulations in Japan, Japan Pharmaceutical Manufacturers Association, available http //www.jpma.or.jp/english/library/pdf/2005. pdf. 

Estrogenic Pharmaceuticals. Administration of estrogenic pharmaceuticals to children or adults can result in a variety of abnormalities associated largely with secondary sex characteristics that are reversible upon cessation of drug treatment. 

Associate Professor, Pharmaceutical, Administrative, and Social Sciences, University of Appalachia College of Pharmacy, Oakwood, Virginia... 

Pharmaceutical review system study group, ministry of health and welfare. In Pharmaceutical Administration in Japan, 9th Ed. Yakuji Nippo, Ltd. Tokyo, 2000 http // WWW. y akuj i. CO. jp. 

Products) 1986. These Directives, issued by the Pharmaceutical Administration, provide detailed instructions and requirements with regard to pharmaceutical registration. 

The Pharmaceutical Administration, a division in the Ministry of Health, is designated as the drug regulatory authority. The Administration handles most other regulatory affciirs issues, cis discussed in the previous chapter. The Institute for the Standardization emd Control of Phcu maceuticals of the Ministry of Health, a unit of the Pharmaceutical Administration, is responsible for issues pertaining to quality. In addition there are regional bureaus of the Ministry of Health responsible for certain aspects of related issues. 

As mentioned before, the Pharmaceutical Administration is the drug regulatory authority and has a wide range of responsibilities, as reflected by the various functional units that follow ... 

The responsibilities of the unit include receiving, processing and evaluating registration applications for human pharmaceutical products. Conditions of marketing and labeling are set by this unit. Marketing authorizations are issued by the Pharmaceutical Administration. 

Direct-to-consumer (DTC) advertising is in principle not allowed. OTC products, however, may be advertised pending approval of the content by the Pharmaceutical Administration. Approval for DTC advertising of prescription products is granted in exceptional cases only. 

Pre-submission dialog The Pharmaceutical Administration can be approached with queries related to the preparation of registration submissions. This is especially desirable regarding the registration of generic products, in order to clarify the need for bioequivalence data as well cis for the clarification of the reference standard. 

In evaluating registration applications the Pharmaceutical Administration may make use of outside expert advice in both preclinical and clinical matters. This will be the case for applications for registration of products containing a new chemical entity or of an additional indication for a drug already registered. 

After a positive decision in principle to approve the application, the Pharmaceutical Administration will determine the conditions for marketing (OTC, prescription-only medicine [POM], etc.) of the approved product, the contents of the patient insert, professional prescribing information and the label requirements and may set additional conditions regarding the marketing of the product. 

A meeting for the submission has to be arranged with the Pharmaceutical Administration. At this meeting the dossier will be checked for completeness with emphasis on availability of complete administrative documentation. 

Application for registration to the Pharmaceutical Administration (See a translation of the application form in Appendix 2). 

Shortly before the product comes up for discussion by the Drug Registration Committee, and at the request of the Pharmaceutical Administration, the applicant will update the file by submitting all relevant articles published after the submission of the application... 

Each pharmaceutical product should be accompanied by consumer information in the form of a package insert in Hebrew cmd Arabic. This leaflet should include directions for use, properties of the product cind contraindications, among others. The Directives include detailed instructions regarding the content of the insert (See Appendix 7). If a leciflet in any additional language is enclosed as well, its text must be an exact translation of the Hebrew text. The content of the insert will be determined by the Pharmaceutical Administration as part of the marketing authorization. 

Application for approval of a trial has to be made by the investigator of the hospital to the Helsinki Committee accompanied by relevant scientific documentation. After approval by the Helsinki Committee the application will be forwarded to the Pharmaceutical Administration in the Ministry of Health. One of the following steps will be executed by the Administration ... 

To Director General, Ministry of Health through the Director of the Pharmaceutical Administration Appliccint (Appointed pharmacist. License number) New Registration/Renewal Previous Reg. No. Fee (cunount) No. of receipt... 

To be filled in by the Dept, of Registration Terms, Pharmaceutical Administration, Ministry of Health... 

To The Director General Ministry of Date of submission Health through the Director of the Pharmaceutical Administration... 

The National Pharmaceutical Administration is staffed by pharmacists who evaluate all applications for product licence, conduct GMP audits in the case of a local manufacturer, conduct post-marketing surveillance and also actively monitor adverse drug reaction reports. 

Applicants are required to complete the prescribed application form (Appendix 1) for a product licence and submit the form to the Drug Administration Division (DAD), National Pharmaceutical Administration and Ministry of Health. Application forms can be obtained from the Cashier, Block 4 of the National Pharmaceutical Administration at No 2, Jalan Bukit Merah, Singapore 169547. In the near future, applicants will be able to download a copy of the application form from the National Pharmaceutical Administration s Internet website. 

Many importing countries require proof of registration of medicinal products in the country of origin before sales are permitted. To assist local manufacturers with export markets, the National Pharmaceutical Administration issues Certificates for Exporter of Medicinal Products to holders of product licences whose locally manufactured products conform to required standards of quality (See Appendix 7). The WHO format is used. 

The Enforcement Division of the National Pharmaceutical Administration carries out a QSP which monitors registered products for compliance with quality specifications. Products are sampled from the manufacturer, importer, wholesale dealer or retailer and are subjected to quality testing against the manufacturer s specifications. 

The recall initiated by the National Pharmaceutical Administration as a result of an ADR report or QSP of registered medicinal products is classified either Class 1 or Class 2 recall depending on the potential hazard of the defective product. 

The completed DRA forms and the required documents, paclmging materials or product samples are to be submitted to the Drug Administration Division, National Pharmaceutical Administration, 2 Jalan Bukit Merah, Block 2, Singapore 169547. 

GMP LICENSING UNIT National Pharmaceutical Administration Ministry of Health 2, Jalan Bukit Merah Singapore 169547 Telefax 325 5594... 

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