See other pharmaceutical books from European Union Publishers on cosmetics, excipients, etc.


  Click here for Pharmacopoeias

Fiedler - Encyclopedia of Excipients. Hoepfner, Eva-Marie; Lang, Siegfried; Reng, Alwin; Schmidt, Peter Christian. due Spring. 2007. 6th ed.  More than 12,900 new and revised excipients arranged according to pharmacopoeia title, INCI, INN, CAS, chemical name and synonyms, formula, etc, preparation, properties, product data, applications, toxicology (with an actual overview of pharmacological and toxicological properties and allergy-induing reactions and FDA status), analytics, references (reviews up to 2005), single products of groups of substances. Encyclopedic entries give a base and overview with general descriptions of raw materials (e.g. Butane, lactose), of substance classes (e.g. eye preparations, moisturizers, plasticizers, tablet excipients), abbreviations of important names and institutions (EINECS). Also has a completely revised manufacturers list with more than 400 firms and websites and current products. A new and revised survey tables for international use with a separate sections for cosmetic ingredients review (CIR), coloring agents for cosmetics and durgs, dangerous substances, food additives, preservatives, sieves, solubilizers, surfactants, etc.  1600 pp. hardcover. 2 volumes. ISBN: 3-87193-346-5. $560.00; CDROM version: ISBN 3-87193-347-3. $560.00

Guide to Drug Regulatory Affairs. B. Friese, B. Jentges, U. Muazzam und Beitr�gen von T. A. Keller, C. Oldenhof, K. Olejniczak, H. Potthast, Joachim A. Schwarz, B. Sickmueller. 2007. This is the first comprehensive overview of the legal and regulatory framework for marketing authorisation applications in Europe, including Switzerland. It gives extensive and valuable advice on how to compile a marketing authorisation according to the CTD format (Modules 1 � 5 CTD). The �Guide� has been developed to penetrate the �regulatory jungle� and make related work much easier and more efficient. With both a printed and a regularly updated online edition, the �Guide� is a multi-media platform designed to support the different needs of its many users.

The Guide is subdivided into four major parts

• Part A: This provides detailed information about different procedures for drug approval, and relevant legislation and requirements that have to be considered when submitting an application for marketing authorisation. Judicial decisions from pertinent European courts are also highlighted.
• Part B: This gives detailed practical advice on how to prepare an application for marketing authorisation and also the accompanying documents which demonstrate quality, safety and efficacy. In addition, aspects of maintaining the marketing authorisation are discussed, covering applications for variations to a marketing authorisation, extension applications and renewal applications. Regulatory compliance issues are considered, and the requirements for IMPDs (Investigational Medicinal Product Dossiers) are included. Marketing authorisation procedures and the regional part of a Swiss marketing authorisation application are also considered.
• Part C: This describes the main provisions relevant to biopharmaceuticals, plant-based traditional medicinal products, blood, blood products and orphan drugs.
• Part D: This includes much additional helpful information: an index of abbreviations, an index of terms and definitions, literature, links etc.
  
  Available as a print or online edition, the �Guide� is a multi-media resource designed to support the different needs of its users.

  Contents � The print edition with more than 800 pages is primarily intended as an invaluable reference-book.

  The key benefits of the constantly updated, user friendly and easily navigated online edition include:

  • Multiple search options, such as full-text, chapters, terms and keywords
  • Constant updates and amendments
  • Comments and interpretation of EMEA and EU news and documents
  • Instant access to all relevant official documents
  • Direct link to EU and EFTA authorities
  • Permanent link check to nearly 700 links mentioned in the Guide
  • Discussion Forum
  • Regular Newsletter
  • Link to upcoming events including conferences and education courses in the field of Drug Regulatory Affairs
  • Job Market

  Target groups:
  - Employees, Executives and Directors of Pharmaceutical Companies and the API Industry (API Active Pharmaceutical Ingredients)
  - Legal Advisers and Attorneys
  - Employees and Heads of Regulatory Authorities
  - Consultants
  - Professionals in Quality Assurance
  - Training in Regulatory Affairs

  ISBN 3-87193-324-4. hardcover. $608.00

Drug approval and licensing procedures in Japan 2011.
Part 1 Outline of Pharmaceutical Regulations According to the Pharmaceutical Affairs Law（薬事法規制の概略）
Part 2 Marketing Approval（製造販売承認）
Part 3 Drug Substances, Pharmaceutical Excipients, Drug Master File, and Drugs Requiring No Approval（原薬、医薬品添加物、原薬等登録原簿、承認不要医薬品）
Part 4 Procedures from Applications for Marketing Approval to Approval（製造販売承認申請から承認までの手続き）
Part 5 Clinical Trials, Orphan Drugs, and Joint Development（治験、希少疾病用医薬品、共同開発）
Part 6 Applications for Marketing Approval for OTC Drugs（一般用医薬品の製造販売承認）
Part 7 Marketing Business License（製造販売業許可）
Part 8 Manufacturing Business License and Accreditation（製造業許可・認定）
Part 9 Exports and Imports（輸出・輸入）
Part 10 Bio-derived Products（生物由来製品）
Appendix1
Appendix, 1000 pages. in Japanese and English. $2000.00

MHLW Ministerial Ordinances on GQP and GMP 2005. April 2006. Provides the whole text of these four MHLW Ministerial Ordinances Established/Revised in 2004/2005. including: Standards for Quality Assurance of Drugs, Quasi-drugs, Cosmetics and Medical Devices [GQP Ministerial Ordinance] (MHLW Ministerial Ordinance No. 136 Established as of September 22, 2004); Regulations for Buildings and Facilities for Pharmacies etc. [Buildings and Facilities Regulations] (MHLW Ministerial Ordinance No. 180 Revised as of December 24, 2005); Standards for Manufacturing Control and Quality Control of Drugs and Quasi-drugs [GMP Ministerial Ordinance on Drugs and Quasi-drugs] (MHLW Ministerial Ordinance No. 179 Revised as of December 24, 2004); Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostics [QMS Ministerial Ordinance on Medical Devices and In Vitro Diagnostics] (MHLW Ministerial Ordinance No. 169 Revised as of December 17, 2004) 234 pages, ISBN4-8408-0842-2 C3047, Paperbound, A5 format (148 x 210 mm) in Japanese and English. $this is out of print right now, a new edition is being considered!

Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulation 2009/2010; This new edition includes revisions promulgated in 2009, and includes the Pharmacist Law and the Nursing Care Insurance Law. $700.00 ( pertains to Japan!)

The Japanese GMP Regulations 2003. Ministry of Health, Labour and Welfare. 2003. Covers regulations for buildings and facilities for pharmacies; regulations for manufacturing control and quality control of drugs; regulations for importing/retail management and quality control of drugs and quasi-drugs; MHLW Ministerial Ordinance on the manufacturing control and quality control when manufacturing of a single product of the drugs, quasi-drugs, cosmetics and medical devices specified under article 1-2-2....; good manufacturing practice guide for active pharmaceutical ingredients. 190 pp, paperback. ISBN 4-8408-0761-2. in English & Japanese. $389.00

Prices may fluctuate with the Currency Exchange Rate!

Back to Home  |  Company Info |   Ordering  |  Shipping & Tracking  |  Publishers  |  Meetings  |  Search  |  Site Index  |  Feedback