Investigation of Approval Trends and Benefits of New Fixed-Dose Combination Drugs in Japan.

BACKGROUND: New fixed-dose combination drugs (FDCs) had been developed in limited numbers in Japan. Since regulatory requirements were relaxed in 2005, 73 new FDCs have been approved by PMDA since 2006. In this study, we investigate trends in new FDCs and their benefits through a questionnaire survey provided to patients and pharmacists. METHODS: The new FDCs were analyzed by therapeutic categories, first approval country and drug lag (DL). Questionnaire surveys were conducted on hypertension, bronchial asthma, and glaucoma in approximately 300 patients and 700 pharmacists in 66 hospitals to investigate the benefits of new FDCs. RESULTS: The highest number of FDCs approved by the therapeutic category was 15 cardiovascular agents. The DL (median) was less than 1 year in several therapeutic categories including cardiovascular agents. The survey results showed that patient compliance improved in 30.8% of the bronchial asthma. Regarding the time and effort required to prescribe these drugs, 32.5% of pharmacists reported "slightly decreased" in bronchial asthma, while 32.0% reported "slightly increased" in hypertension. More than one-third (70.6%) responded "recommend" in bronchial asthma. CONCLUSION: The number of new FDCs markedly increased since 2006, and this presented new opportunities for the Japanese pharmaceutical industry. FDCs not only increase convenience to the patient but also improve patient compliance and the efficiency of pharmacist prescription processes. However, the rapid increase in new FDCs may cause confusion in the medical field, and new FDCs should be developed not only to improve convenience but also to consider the benefits they provide to patients, pharmacists, and physicians.

Influence of Drug Lag on New Drug Label Revisions.

BACKGROUND: Drug lag (DL) in Japan has decreased in the last few years as a result of the globalization of drug development in the past decade, and new molecule entities (NMEs) with short DL are on the rise. The purpose of this study was to investigate the influence of DL on postmarketing safety of NMEs, by comparing the length of DL and the chronological trend of package insert revisions. METHODS: The number of label revisions occurring during 6 years after approval was investigated for 142 NMEs approved between 2000 and 2006. The NMEs were classified by the length of DL (2 years and 4 years), and the label revision trends by each label section and therapeutic categories were analyzed. RESULTS: The cumulative number of level revisions in the "Drug Interactions" and "Clinically Significant Adverse Reactions" sections in the first year after approval in the DL <2 years group was significantly greater than in the DL ≥2 years group. In the chemotherapeutic category that showed the shortest DL, the first label revision occurred in 33.3% within the first year and in 66.7% by the second year, and label revisions were performed earlier than in any other therapeutic categories. CONCLUSIONS: These results suggest that the package inserts of NMEs with a shorter DL tend to be revised earlier and more frequently, and it requires more careful monitoring of safety information after product launch.

What Drives Adoption of National Labels as Global Reference Labels? A Case Study With the JPI.

Pharmaceutical labeling describes the safe and effective use of an approved product. Such information may be provided to consumers and/or health care physicians, and available online or in the pack in a variety of different formats according to local or regional regulations. Depending on the Health Authority (HA), content within a nationally approved label is generally reliant on two primary sources, a Company Core Data Sheet (CCDS), and the text approved by the Health Authority. Content in the nationally approved label may differ from the CCDS for a variety of reasons. In some countries, HAs require the Marketing Authorization Holder (MAH) to base their national label on an already approved label in a "major market" economy, only approving changes to the label when there is evidence that the major market has already approved. In this paper, we examine recent steps taken by the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) to change labeling regulation in Japan in the context of the recently communicated national strategy, and assess whether this may impact on uptake of the J-PI as a reference label. Decreases in approval times by PMDA for new products, development of basic principles on multiregional clinical trials, greater transparency of content on the PMDA website, and increasing outreach to other Asian Agencies in recent years are highlighted. Labeling harmonization across regions, particularly of safety-related information, represents a key factor in promoting patient safety and risk communication, and is a worthy topic for future ICH consideration.