Abstract
The IMPACT did not explicitly define substandard medicines. This may be explained by the existence of the premise that “specification” is a self-evident thing. For manufacturing pharmaceutical products, there exist international concepts and norms integrated into the undertaking of Good Manufacturing Practice (GMP), which suggest the premise that if a medicine complies with the GMP, its quality will be controlled. When poor quality drugs are discussed, there is a tendency for concluding that such drugs are related to technical problems in terms of GMP, except when they involve criminal activity. The fact that modern medicines have specifications as industrial products has yielded many advantages. Specifically, drug regimens have become interchangeable beyond borders, and technology transfer has become practical, facilitating the spread of manufacturing and use of medicines across the world. Furthermore, specification and standardization of pharmaceutical products have resulted in stricter identification of disease concepts, and in more clear and precise decision-making for the indications of pharmaceuticals, which has formulated a positive cycle enabling further development of medicines. On the other hand, the spread of medicines across the world has also brought about the possibility of disseminating problems associated with product quality.
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Notes
- 1.
In the section “Introduction” of ICHQ6A, it is stated as follows: “A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. ‘Conformance to specifications’ means that the drug substance and/or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval.”
- 2.
Interview conducted by the author 18 November 2014 in Tokyo.
- 3.
In the pharmaceutical industry in Japan, it is understood by custom that blockbuster drugs are those that generate total global annual sales of at least 100 billion Japanese Yen a year for the pharmaceutical companies that sell them.
- 4.
Strictly speaking, clinical studies to compare a generic with its counterpart originator are necessary to verify the clinical equivalence between the two. However, there are criticisms that implementation of such clinical comparative studies waste medical resources, i.e., patients, and imposes too much economic burden to generic manufacturers that have to strive against many competitors.
- 5.
The Japan Pharmaceutical Manufacturers Association (JPMA) states in its website as follows: “The problem with access to medicines cannot be resolved only by issuing compulsory licenses. If an issuance of compulsory licenses lacks rationality and transparency, then it may raise concerns over difficulties in making adequate investment for research and development. We will continue to have dialogues with governments of other countries for the purpose of enhancing sustainable access to medicines.”.
- 6.
The titles of quality-related ICH Guidelines Q8 through Q10 are as follows: Q8: Pharmaceutical Development; Q9: Quality Risk Management; and Q10: Pharmaceutical Quality System.
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Kimura, S., Nakamura, Y. (2020). Quality and Standardization for Globalization. In: Poor Quality Pharmaceuticals in Global Public Health. Trust, vol 5. Springer, Singapore. https://doi.org/10.1007/978-981-15-2089-1_4
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