A study of new drug approval pattern of a Southeast Asian developed country from 2017 to 2021

Background: The pattern of new drug approval is changing across the world as shown by the study using Center for Drug Evaluation and Research and European Medicines Agency data in US and UK with more drug approval for anti-cancer and immunomodulator drugs. There is a need to generate similar database for developed South East Asian countries too. Aims and Objectives: This study was conducted for one such country- Singapore for the new drug approval pattern of last 5 years (2017–2021). Materials and Methods: This was a pharmacoepidemiological study, in which government drug regulatory website data available in public domain was searched. The new drug approval data were classified according to active ingredient, drug approval date, new drug application category, indication of drugs, and World Health Organization Anatomic Thoracic Classification. Results: In this study, 418 new drug approvals were found in last 5 years in Singapore. From this maximum, drug approvals were given to anti-neoplastic and immunomodulator category drugs. In anti-neoplastic category new drugs approval few examples were Trastuzumab deruxtecan and Tucatinib for breast cancer therapy and Tepotinib and Capmatinib for non-small cell lung cancer therapy. Conclusion: This study shows that drug development in anti-cancer drug and immunomodulator is significant in Singapore. This trend is quite matching with other country such as US and UK.

Key points of toxicology research in international registration of botanical drugs / 中国药理学与毒理学杂志

In recent years, traditional Chinese medicine (TCM) has made great progress in the process of internationalization,but the share of TCM is still insignificant in the international market.One of the reasons is that it is difficult to submit the documents in accordance with the drug registration reguirements of Europe and America. In this paper,the requirements of the international drug registration of botanical drugs are briefly introduced,involving the status of botanical drug international registration, the provisions of toxicological studies on botanical drug registration requirements in the United States and Europe, the difference in toxicological research between China and the United States, and the focus of the international registration of toxicological research.

Overviews and analysis of the U.S. FDA′s new approvals in the 2016 second half year / 国际药学研究杂志

In the second half of 2016,the U.S. Food and Drug Administration(FDA)approved 7 new molecular entities and 3 new Biologic License Application(BLA), the lowest number in recent years. According to the prescription information for profes-sionals,this article introduced the description,mechanism of action and clinical studies and briefly describes the boxed warning,indi-cations and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reac-tions,drug interaction and the use in the special population. In addition,the first and critical events in the history of new drug develop-ment and reaserch were emphasized.

New drugs approved by the U.S. FDA(2007-2016):a review / 国际药学研究杂志

The introductions of the new drugs approved by the U.S. FDA have been published in the“Journal of International Pharmaceutical Research”for ten years. However,new problems might emerge with the increasing clinical practice and the cumulative number of patients being treated,such as the indications and purposes change,supplement of the modified efficacy,clinical data and the important new indications,constant improvement of the dosage,form and mode of administration,and the emergence of new,seri?ous and even fatal adverse reactions urge the supplements of contraindications,warnings and precautions,or even the black box warn?ings. In brief,6 entries of the introductions all may be modified,supplemented or canceled. More importantly,ten years of general analyses also find some prominent events,such as the amount of new molecular entity(NME)and new biological products come to an obvious peak in 2015. With regard to this,this paper reviewed the prominent historical events happened in the ten years in order to provide guidance and reference for new drug research and development.

Overviews and analysis of the U.S. FDA′s new approvals in the 2015 second half year / 国际药学研究杂志

In the second half year of 2015,the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti?ties single or compounds and 15 biologics license applications,a total of 35 which record number of approved innovative drugs. Ac?cording to the prescription information for professionals,this article briefly describes the description,mechanism of action and clinical studies,the box warning,indications and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reactions,drug interaction and use in special population of these new drugs. In addition,the first and criti?cal events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in the first half year of 2016 / 国际药学研究杂志

In the first half year of 2016,the U.S. food and drug administration(FDA)approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals,this article introduces the description, mechanism of action and clinical studies;briefly describes the box warning,indications and usage,dosage and administration,dos?age form and strength,contraindications,warning and precautions,adverse reactions,drug interaction and use in special population of these new drugs. In addition,the first and critical events in the history of new drug development and reaserch are emphasized.

New drugs approved by the U.S. FDA (2007-2016): A review / 国际药学研究杂志

The introductions of the new drugs approved by the U.S. FDA have been published in the“ Journal of International Pharmaceutical Research ”for ten years. However, new problems might emerge with the increasing clinical practice and the cumulative number of patients being treated, such as the indications and purposes change, supplement of the modified efficacy, clinical data and the important new indications, constant improvement of the dosage, form and mode of administration, and the emergence of new, serious and even fatal adverse reactions urge the supplements of contraindications, warnings and precautions, or even the black box warnings. In brief, 6 entries of the introductions all may be modified, supplemented or canceled. More importantly, ten years of general analyses also find some prominent events, such as the amount of new molecular entity (NME)and new biological products come to an obvious peak in 2015. With regard to this, this paper reviewed the prominent historical events happened in the ten years in order to provide guidance and reference for new drug research and development.

Overviews and analysis of the U.S. FDA’ s new approvals in the first half year of 2016 / 国际药学研究杂志

In the first half year of 2016, the U.S. food and drug administration (FDA) approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in the 2015 second half year / 国际药学研究杂志

In the second half year of 2015, the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti-ties single or compounds and 15 biologics license applications, a total of 35 which record number of approved innovative drugs. Ac-cording to the prescription information for professionals, this article briefly describes the description, mechanism of action and clinical studies, the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and criti-cal events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in first half year of 2015 / 国际药学研究杂志

In the first half year of 2015, the U.S. Food and Drug Administration(FDA) approved 11 new molecular entities and 5 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug reaserch and development are emphasized.

Overviews and analysis of the U.S. FDA’s new approvals in first half year of 2015 / 国际药学研究杂志

In the first half year of 2015, the U.S. Food and Drug Administration (FDA) approved 11 new molecular entities and 5 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug reaserch and development are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in 2014 first half year / 国际药学研究杂志

In the first half of 2014, the U.S. Food and Drug Administration (FDA) approved 46 new drugs, including 10 new molecular entities and 10 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies, briefly describs the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the “first events” in the history of new drug research, development and approval are also discussed.

Overviews and analysis of the U.S. FDA's new approvals in 2014 first half year / 国际药学研究杂志

In the first half of 2014, the U.S. Food and Drug Administration (FDA) approved 46 new drugs, including 10 new molecular entities and 10 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies, briefly describs the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the “first events” in the history of new drug research, development and approval are also discussed.

Overviews and analysis to the U. S. FDA's new approvals in 2012 / 国际药学研究杂志

In 2012, the U. S. Food and Drug Administration (FDA) approved 34 new drugs, including 23 new molecular enities and 11 new biological products. According to he prescription nformation for professionals, this article briefly describes he description, mechanism of action, the box warning, indications and usage, dosage and administration, dosage form and strength, contrandications, warning and precautions, adverse reactions, drug nteraction and use of these new drugs n special population. In addiion, the first events n he history of new drug research, development and approval are also discussed.

Introduction and analysis to the U.S. FDA's new drug approvals in 2010 / 国际药学研究杂志

In 2010, the U.S. FDA totally approved 24 new drugs, including 11 new molecular entities, 10 new biological products and 3 new vaccines. According to the prescribing information of drug specifications, this article outlines the properties, chemical name and structure, action of mechanism, manufacturer, indication, dosage and usage, contraindications, adverse reactions, boxed warning and other relevant informations of them. In addition, the "first events" in the history of new drug research and development in 2010 are also summarized, and the overview of the new drugs approval by FDA from the years of 2008 to 2010 is also analyzed.