Japanese Pharmaceutical Excipients Industry Overview: Standard Setting In Various Forms - Medical

Japanese pharmaceutical preparations Accessories Most of the chemical

, food processing plants or light industrial production, after passing inspection by the relevant standard to use. Drug Registration Review Japan stressed accessories shall not affect the preparation of a dosage, efficacy and test preparation, which called for adding accessories can be obtained by the agent to maintain good stability and solubility. But if it led to full effect does not affect its safety or Drug Quality To judge when the case is still not allowed to use the kinds of accessories. Therefore, Japan for the assessment of pharmaceutical excipients, in addition to its component features accessories, but also include added accessories of preparation of the overall evaluation.

The management of new accessories

In Japan, new accessories medicines containing the application, you need to submit the origin of the accessories, the development overview, foreign use status information, as well as the physical and chemical properties, specifications and test methods, etc., the stability information and data relating to toxicity. At present, Japan does not Pharmaceutical Excipients Itself prior evaluation, that is its consideration of new accessories, auxiliary materials actually used in the new medicine, together with the new excipients on drug efficacy, safety and quality of evaluation, including review together, do not accept only obtain the approval of new excipients alone made the application.

Accessories diverse standards

Japanese pharmaceutical preparations accessories in various forms in the standard formulation, in addition to "Japanese Pharmacopoeia" (Japan Pharmacopoeia ) Received some pharmaceutical preparations containing accessories, there are specific statutory standards for medicinal preparations accessories "Medicines additive specifications" (collection contained species other than Pharmacopoeia, referred to as "medicine Tim regulation x", the English name for short "JPEx" , x for the version of the reign). The standard security by the Japanese Ministry of Health Medical Board reviewed the management organization, the National Pharmaceutical Food Research Institute, Tokyo Medical Products Industry Association, the Osaka Pharmaceutical Association, the Japan Pharmaceutical Manufacturers Associations, Japan Pharmaceutical Association and the Japan Additives Surfactant Industry to take part in the formulation, revision once every three, according to the revision Pharmacopoeia and actual use of a species change and content modified. Under each species include: sources, properties, confirmatory test (check method), the purity test, dry weight loss, quantitative method (based on different varieties and some without this), method of storage, route of administration (oral, topical, injection, etc. ) and other species vary with the particular standard inspection items.

In addition, the Japanese Association of Pharmaceutical Additives, compiled and published "Code of Pharmaceutical Additives things" (medicinal preparations accessories manual), the manual has been fully documented in Japan licensed medicinal preparations used ingredient name and the use of excipients way, the biggest such use, an essential reference for the pharmaceutical manufacturers, the manuals to determine whether the declaration by adding new accessories when drugs have important reference value. All varieties under include: name, English name, aliases, chemical name, structural formula and molecular weight, and references (income contained in the standard source and other important documents), summary (Appearance and solubility, pH value), reference standard ( detection index that content and impurities), storage methods, purposes (preparation time can be used as stabilizers, flavoring agents have been approved using the precedent purposes), route of administration and maximum dosage, trade names and manufacturers.

Similar with the United States, Japan, the management of the excipients is targeted, focused accessories route of administration; of new accessories stressed that if there are applications in pharmaceuticals. In addition, the Japanese industry associations in the management and use of accessories also play an important role in the government approval of the supplementary material on the basis of standard content, an increase of pharmaceutical companies face more relevant information to be learned from these practices. However, Japan's role in pharmaceutical excipients description of knowledge is still not accurate, such as: continue to believe that accessories or agents shall not affect the safety inspection, which is not entirely consistent with the actual situation, because some accessories can reduce the side effects of agents ( injection of local anesthetic used), and some accessories though the impact test preparation, but can build new test method to solve them.

by: gaga

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