| Title |
Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects
|
|---|---|
| Published in |
The AAPS Journal, May 2015
|
| DOI | 10.1208/s12248-015-9777-x |
| Pubmed ID | |
| Authors |
Ryosuke Kuribayashi, Maki Matsuhama, Kenichi Mikami |
| Abstract |
Generic drugs are interchangeable with original proprietary drugs, as they have the same active pharmaceutical ingredients, dosage forms, strength, quality, indications, effects, directions, and dosage. The cost of generic drugs is lower than original drugs, because the developmental cost is lower. The expansion of medical expenses is an important issue in many countries, including Japan, the USA, and Europe, and promotion of generic drugs has been demanded to solve this issue in Japan. Generic drug approval review in Japan is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), which reviews the equivalence of the original drugs from the viewpoint of quality, efficacy, and safety, based on documentation submitted by the generic drug applicants. However, the details of the generic drug review in Japan have not been reported. In this report, we introduce the application types, the number of applications and approvals, and the review timeline of generic drugs in Japan. In addition, we discuss recent consultations and future prospects. |
Mendeley readers
The data shown below were compiled from readership statistics for 47 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 47 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 9 | 19% |
| Researcher | 6 | 13% |
| Student > Ph. D. Student | 5 | 11% |
| Student > Bachelor | 2 | 4% |
| Professor | 2 | 4% |
| Other | 9 | 19% |
| Unknown | 14 | 30% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 13 | 28% |
| Medicine and Dentistry | 7 | 15% |
| Chemistry | 3 | 6% |
| Business, Management and Accounting | 2 | 4% |
| Nursing and Health Professions | 2 | 4% |
| Other | 6 | 13% |
| Unknown | 14 | 30% |
Attention Score in Context
This research output has an Altmetric Attention Score of 6. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 07 July 2015.
All research outputs
#5,744,947
of 22,817,213 outputs
Outputs from The AAPS Journal
#317
of 1,287 outputs
Outputs of similar age
#67,630
of 264,474 outputs
Outputs of similar age from The AAPS Journal
#9
of 32 outputs
Altmetric has tracked 22,817,213 research outputs across all sources so far. This one has received more attention than most of these and is in the 74th percentile.
So far Altmetric has tracked 1,287 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.0. This one has done well, scoring higher than 75% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 264,474 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 74% of its contemporaries.
We're also able to compare this research output to 32 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 71% of its contemporaries.