International harmonization process

Positive-displacement pumps are subject to flow instability, which is created either by process restrictions or by the internal pumping process. Increases in amplitude at the passing frequencies, as well as harmonics of both shafts running speed and the passing frequencies, typically result from instability. 

The first edition1 of this book was published approximately 13 years ago. Its primary objective was to present an overview and a "roadmap" of the process of new drug discovery and development, particularly oriented to individuals or companies entering the pharmaceutical field. It was written by one of the authors (Smith), with no contributors, and drawn on Smith s experiences in the industry and field over the course of nearly 40 years. In the second edition, the scope of the first book has been expanded and technical details in the form of hard data have been included. In addition to the editors own commentary and contributions, the major part of the book is the result of contributions of experts in the industry. New chapters on risk assessment, international harmonization of drug development and regulation, dietary supplements, patent law, and entrepreneurial startup of a new pharmaceutical company have been added. Some of the important, basic operational aspects of drug discovery and development (e.g., organizational matters, staff requirements, pilot plant operations, etc.) are not repeated in this book but can be found in the first edition. 

In 1996, the VICH program was officially launched among the European Union, Japan, and the United States (52). Among the objectives of the VICH is to provide a forum for a constructive dialogue between regulatory authorities and the veterinary medicinal products industry on the real and perceived differences in the technical requirements for product registration in die three jurisdictions, with tlie expectation that such a process may serve as a catalyst for a wider international harmonization. VICH should identify areas in which modifications... 

Abstract By the definition of the mole as a base unit for amount-of-substance measures within the International System of Units (SI), chemists can make chemical measurements in full compliance with established metrological principles. Since the mole requires exact knowledge of the chemical entity, which is often neither available nor of practical relevance to the purpose of the measurement, the SI units of mass or length (for volume) are unavoidable in the expression of results of many chemical measurements. Science, technology, and trade depend upon a huge and ever increasing number and variety of chemical determinations to quantify material composition and quality. Thus, international harmonization in the assessments of processes, procedures, and results is highly desirable and clearly cost effective. The authors, with relevant experience and re-... 

Given that global trade and international harmonization are key to the development of a sustainable life sciences industry, closer international cooperation is key to tackling technical barriers to trade in medicines. In addition to the ICH process, increasingly regulatory authorities have entered into agreements to enable them to exchange confidential information about approval and safety of medicines. 

All the above-mentioned legal treatises apply to the European Economic Area (EEA this comprises the 27 EU member states plus Liechtenstein, Iceland, and Norway—Switzerland chose by referendum not to join the EEA, but has certain Swiss-EU bilateral agreements). Switzerland acts as the representative of the European Free Trade Association, which is an observer in the ICH (International Conference on Harmonization) process, accepts ICH guidelines, but is not part of the European Economic Area. There is a legal obligation for the Swiss competent authority, Swiss Agency for Therapeutic Products (Swissmedic), to take account of decisions/authorizations in other territories that have equivalent medicinal product control. 

After finalization by each panel, all drafts for revision are opened for public comment through the JP Forum, a vehicle for notification and commentary. The JP Forum is published quarterly by the Society of Japanese Pharmacopeia under the auspices of the JP secretariat. The JP Forum was first published in January 1992 as a medium for both local and international communication. It will continue to provide a more open revision process for the JP and announce revisions and future directions of the JP committees. The JP Forum is issued in Japanese, primarily for domestic users, but articles related to the international community and commentary will be issued in English concurrently with the Japanese version. Therefore, we anticipate that the JP Forum will aid in the process of international harmonization and will promote a better understanding of and increased trust in the JP. 

In the licensing process, it is essential for each regulatory authority to recognize as equivalent those test procedures that have been harmonized and adopted as validated methods by the PDG. This concept is already included in the Japanese Guidelines for Preparation of Section B of the Documents Accompanying New Drug Applications as of September 1995 in its assertion that, The analytical procedures in the Japanese Pharmacopeia and other compendia and those which are accepted through international harmonization are considered to be validated methods. ... 

Committee of Revision, summaries of issues discussed by the Drug Standards Division Executive Committee, and various tabulations or lists that aid in keeping track of the multifaceted revision program. A section called Stimuli to the Revision Process publishes reports or statements of authoritative committees, scientific articles relevant to compendial issues, general commentaries by interested parties, and collations of comments received in response to policy initiatives. A recent addition is a section on International Harmonization. 

Nightingale, S. International Harmonization The ICH Process as a Model for Government and Industry Collaboration. Swiss Pharma 16 (1994) 59-63. 

From the early 90 s onwards, the International Conference on Harmonization was initiated in three important pharmaceutical regions (Europe, Japan, USA) in order to define a common way of preparing a registration file acceptable in the three zones. The topics included in this harmonization process are ... 

The present publication reflects the need, often expressed by Member States, for internationally harmonized criteria for the safe underground disposal of high level radioactive wastes. It sets out a basic safety philosophy for use in planning such disposals, the main objective of which is the isolation of the radioactive wastes from the human environment for considerable periods of time. The basic requirements for the protection of humans arise directly from radiation protection principles extended so as to deal with events and processes that can occur in a deep underground repository in the far future. Technical criteria regarding the waste, the repository and its environs are also specified as a basis for assuring compliance with the safety principles. 

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