Trends in sales of drugs for asthma in New Zealand,Australia, and the United Kingdom, 1975-81.

As part of an investigation into the recent epidemic of deaths from asthma in New Zealand, trends in the sales of drugs for asthma in New Zealand, Australia, and the United Kingdom during 1975-81 were examined. Data on sales of drugs were obtained from an international pharmaceutical market research organisation. A striking increase in sales of sympathomimetic aerosols, steroid aerosols, and theophylline per caput occurred in all three countries, with the greatest increase occurring in New Zealand. Sales of sodium cromoglycate also increased in New Zealand and the UK but fell in Australia. By 1981 New Zealand had the highest sales of all these drugs per caput. Explanations for the rising mortality from asthma in New Zealand despite large increases in drug sales need to be explored. Although the temporal association between mortality and sales of drugs suggests that direct drug toxicity is unlikely, there may be more subtle adverse effects of drug use.     

Letter from the Editor

With annual healthcare expenditures on the order of $2 trillion, the US leads the world in spending but has done relatively little research on the effective use of those funds. Other countries, including Australia, Canada, France, Germany, and the United Kingdom (UK) have instituted various types of health technology assessment or evaluation. Sweden was an early adopter with the establishment in 1987 of the Swedish Council on Technology Assessment in Health Care. UK’s National Institute for Health and Clinical Excellence (NICE), which includes the Centre for Health Technology Evaluation, followed in 1999. Economic modeling of cost effectiveness is integral to NICE’s assessment of new medical technologies. The US has not lagged other countries in principle – the Agency for Healthcare Research and Quality (AHRQ) had a medical treatments effectiveness program as early as 1989 - but funding levels for such programs have been low in the past, and comparative effectiveness research (CER) results have generally not had a notable impact on medical or reimbursement policies, in part because Congress has not allowed CER outcomes to impact coverage decisions.     

Review of invertebrate biological control agent regulation in Australia, New Zealand, Canada and the USA: recommendations for a harmonized European system

Europe lags far behind Australia, New Zealand, Canada and the USA in terms of implementing regulatory procedures for the import and release of invertebrate biological control agents (IBCAs). A number of standards, documents and guidelines have been produced over recent years in an attempt to harmonize regulation of IBCA introduction into Europe. Despite these efforts, the number of member countries implementing any form of IBCA regulation remains low, with many industries, biological practitioners and regulators fearing that a regulatory system would render the process of approval for IBCA introduction into a country costly and time consuming. Europe’s priority is therefore to formulate a regulatory system that will be readily approved of and adopted by all member countries. In this paper we review the current regulatory processes operating in Australia, New Zealand, Canada and the USA. There is potential for Europe to benefit from the years of experience that these countries have in IBCA regulation. We therefore propose recommendations based on features of the regulatory processes in each of the four countries that work well and that could be adopted to generate a workable Europe‐wide regulatory system.     

Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa,Canada, 14 May 2012

In May 2012, Health Canada and other participants held a National Summit on Subsequent Entry Biologics (SEBs). Health Canada released a guidance document in March 2010 describing policy positions and data requirements for approval of SEBs. While Health Canada and health agencies in other regulatory jurisdictions are aligned on many scientific principles related to biosimilar drugs, Health Canada's specific requirements may not be widely understood by many Canadian stakeholders. The Summit provided an opportunity for education and dialog among physicians who prescribe biologics, provincial payers, and industry on the following topics: preclinical and clinical comparability studies; manufacturing and other product differences; extrapolation of indications; substitution and interchangeability of SEBs with reference biologic drugs in clinical practice; payers' current perspective; pharmacovigilance and naming. It is anticipated that the consensus reached at this meeting will further educate Canadian healthcare professionals, provincial payers, and insurers about the appropriate use of SEBs, and may be of general interest to others internationally.     

International Migration of Doctors,and Its Impact on Availability of Psychiatrists in Low and Middle Income Countries

Background

Migration of health professionals from low and middle income countries to rich countries is a large scale and long-standing phenomenon, which is detrimental to the health systems in the donor countries. We sought to explore the extent of psychiatric migration.

Methods

In our study, we use the respective professional databases in each country to establish the numbers of psychiatrists currently registered in the UK, US, New Zealand, and Australia who originate from other countries. We also estimate the impact of this migration on the psychiatrist population ratios in the donor countries.

Findings

We document large numbers of psychiatrists currently registered in the UK, US, New Zealand and Australia originating from India (4687 psychiatrists), Pakistan (1158), Bangladesh (149) , Nigeria (384) , Egypt (484), Sri Lanka (142), Philippines (1593). For some countries of origin, the numbers of psychiatrists currently registered within high-income countries'' professional databases are very small (e.g., 5 psychiatrists of Tanzanian origin registered in the 4 high-income countries we studied), but this number is very significant compared to the 15 psychiatrists currently registered in Tanzania). Without such emigration, many countries would have more than double the number of psychiatrists per 100, 000 population (e.g. Bangladesh, Myanmar, Afghanistan, Egypt, Syria, Lebanon); and some countries would have had five to eight times more psychiatrists per 100,000 (e.g. Philippines, Pakistan, Sri Lanka, Liberia, Nigeria and Zambia).

Conclusions

Large numbers of psychiatrists originating from key low and middle income countries are currently registered in the UK, US, New Zealand and Australia, with concomitant impact on the psychiatrist/population ratio n the originating countries. We suggest that creative international policy approaches are needed to ensure the individual migration rights of health professionals do not compromise societal population rights to health, and that there are public and fair agreements between countries within an internationally agreed framework.     

预测：2016年FDA即将批准新药概述

2015 年全年美国 FDA 共批准 45 个新分子实体和新生物制品,本文列出了 2016 年可能获 FDA 批准的新药目录,并对具体批准日 期进行了预测。     

Amivantamab and Mobocertinib in Exon 20 insertions EGFR Mutant Lung Cancer,Challenge To The Current Guidelines

In 2021, the US Food and Drug Administration (FDA) approved two drugs targeting exon 20 directly: amivantamab and mobocertinib, under the accelerated approval pathway, for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Here we discuss questions regarding the core question of an “unmet need” within the accelerated approval pathway, contending that equipoise remain between the new compounds and previously existing options. Second, the NCCN's guidelines are currently recommending to sequence both drugs, a recommendation that is not based on any data. Last, post-marketing requirements may not shed clarity in the setting of these approvals. Our analysis has implications beyond patients with exon 20 insertion. In an era with growing identification of new and rarer molecular entities, misguided incorporation of new compounds into practice may obstruct trial enrollment in decisive clinical trials.     

2016 年7 月美国、欧盟和日本新批准药物概述

2016 年7 月,美国、欧盟和日本共批准36 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。 对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。     

2016 年 12 月美国、欧盟和日本新批准药物概述

2016 年 12 月,美国、欧盟和日本共批准 42 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。 对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。     

2016 年9 月美国、欧盟和日本新批准药物概述

2016年9月,美国、欧盟和日本共批准49个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。     

2016 年6 月美国、欧盟和日本新批准药物概述 孙友

2016 年6 月,美国、欧盟和日本共批准21 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。 对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。     

2015 年 11 月美国、欧盟和日本新批准药物概述

2015 年 11 月,美国、欧盟和日本共批准 36 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。 对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。     

2016 年 1 月美国、欧盟和日本新批准药物概述

2016 年 1 月,美国、欧盟和日本共批准 25 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。对 全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。     

2017 年 2 月美国、欧盟和日本新批准药物概述

2017 年 2 月,美国、欧盟和日本共批准 16 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。 对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。     

2015 年 12 月美国、欧盟和日本新批准药物概述

2015 年 12 月,美国、欧盟和日本共批准 23 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。对 全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。 [ 关键词 ] 新药批准;临床试验;新分子实体;新生物制品     

2016 年5 月美国、欧盟和日本新批准药物概述

2016 年5 月,美国、欧盟和日本共批准32 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。 对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。     

2016 年8 月美国、欧盟和日本新批准药物概述

2016 年8 月,美国、欧盟和日本共批准24 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。 对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。     

2016 年4 月美国、欧盟和日本新批准药物概述

2016 年4 月,美国、欧盟和日本共批准42 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。 对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。