2. Japanese Pharmaceutical Regulation's Paradigm Shift to Real-world Data Utilization in Pharmacovigilance / 薬剤疫学

In these days, Japanese regulatory reform toward Real World Data (RWD) utilization in Pharmacovigilance (PV) has been carried out. One of the major changes is the amendment of “Ministerial Ordinance on Good Post-marketing Study Practice for Drugs” (No. 171, Ministry of Health, Labour and Welfare, dated December 20, 2004) implemented in April 2018. In this amendment, it clearly defines “Post-marketing database study” as one of post-marketing studies conducted by pharmaceutical companies. However, it does not mean that conventional post-marketing studies (e.g.；enrolling a few thousands patients in a single cohort study with primary data collection), can be simply replaced by the “Post-marketing database study” . The RWD utilization could be a trigger to accelerate efforts on pharmacovigilance in Japan for selecting the best method based on the issue to be addressed.

A preliminary study on the impact and its mechanism of pharmaceutical regulation on the firm performance / 中国药学杂志

OBJECTIVE: To study the impact and its mechanism of pharmaceutical regulation on the firm performance. METHODS: To make the multiple regression analysis with the pharmaceutical regulation intensity as independent variable, profit rate as dependent variable, R&D innovation and firm investment as intervening variable, based on the pharmaceutical industry data of China. RESULTS: The relationship between the pharmaceutical regulation intensity and profit rate is significantly positive correlation, for which the R&D innocation plays a role of mediation. CONCLUSION: Pharmaceutical regulation stimulates the R&D revenue and enhances technical innovation, and thus the innovation achievement enhances the firm performance. The increase of firm performance brought by innovation compensates the drop by regulation cost.

A tragédia da talidomida: a luta pelos direitos das vítimas e por melhor regulação de medicamentos / The thalidomide tragedy: the struggle for victims' rights and improved pharmaceutical regulation

Resumo A tragédia da talidomida, no final dos anos 1950, constituiu um divisor de águas na regulação de medicamentos. Novos usos da droga estão sendo pesquisados e implementados atualmente. O artigo revisita a história da talidomida e seus desdobramentos no plano regulatório e dos direitos das vítimas no Brasil, com base em revisão de literatura, análise documental e reportes de jornais. Destaca que os eventos evidenciaram a carência de normas fortes para o uso seguro de medicamentos e mostra que a transformação dos acontecimentos em um problema público, mediante sua veiculação na mídia, e a crescente mobilização das vítimas foram forças essenciais que pressionaram por uma regulação de medicamentos mais efetiva.

Abstract The thalidomide tragedy in the late 1950s was a watershed moment for pharmaceutical regulation. New uses for this medication are being researched and implemented today. This article revisits the history of thalidomide and its consequences for regulation and for victims' rights in Brazil, based on a literature review, documentary analysis, and newspaper reports. The events highlighted herein show the lack of strong standards for safe medication use, as well as how the tragedy was transformed into a public problem through its divulgation in the press; the article also shows that the increasing mobilization of victims was essential in pushing for more effective drug regulations.

Guía dirigida al farmacéutico que labora en asuntos regulatorios, sobre las funciones que debe cumplir en la vigilancia sanitaria del medicamento / Guide addressed to the pharmacist who works in regulatory affairs, on the functions that must be fulfilled in the sanitary surveillance of the drug

En Venezuela el Ministerio del Poder Popular para la Salud a través del Servicio Autónomo de Contraloría Sanitaria y el Instituto Nacional de Higiene "Rafael Rangel", regula lo concerniente a los medicamentos, siendo las principales funciones las siguientes: inspección de Buenas Prácticas de Manufactura, autorización de protocolos clínicos, registro sanitario, liberación de cada lote a comercializar, vigilancia farmacológica (farmacovigilancia), programa de control de productos comercializados. El Ministerio del Poder Popular para la Salud como Autoridad Regulatoria lleva a cabo los programas dirigidos a la prevención que proporcionan garantía a la población en la reducción de los riesgos al someterse a un tratamiento terapéutico, tiene carácter eminentemente preventivo y además colectivo redundando en el aseguramiento de la mejor calidad de vida de los pacientes durante los tratamiento. La vigilancia sanitaria de medicamentos es de gran importancia y debe aplicarse de manera ininterrumpida y eficaz, siendo el farmacéutico en asuntos regulatorios un ente responsable de esto como protagonista principal del medicamento, que debe trabajar en conjunto con la Autoridad Regulatoria y aliado a las regulaciones farmacéuticas vigentes, por esta razón, en la investigación, se planteó como objetivo general: elaborar uno guía dirigida al farmacéutico que labora en asuntos regulatorios, sobre las funciones que debe cumplir en la vigilancia sanitaria de medicamentos, a fin de que puedan coordinar, regular, evaluar, vigilar los medicamentos; para obtener este resultado, se revisó la normativa nacional e internacional existente relacionada con la vigilancia sanitaria de medicamentos y se desarrollaron las actividades y responsabilidades del farmacéutico en asuntos regulatorios en cada uno de los procesos involucrados en la vigilancia sanitaria de medicamentos.

In Venezuela, the Ministry for the Pupolar Power of Health, through the Autonomous Service of Sanitary Controllership and the National Institutte of Hygiene "Rafael Rangel", regulates what is concerned to medicines being the principal functions the following ones: inspection of Good Practices of Manufacture, authorization of clinical protocols, sanitary registering, liberation of every batch being commercialized, pharmacological vigilance (pharmacovigilance), program of control of commercialized products. The Ministry for the Pupolar Power of Health as Regulative Authority carries out directed activities towards prevention that is guarantee to population for the reduction of the risks on having surrendered to a therapeutic treatment. It has eminently preventive character in addition to collective redounding to the insurance of the best quality of life for patients during the treatments. The sanitary vigilance of medicines shows great importance be applied in an uninterrupted and effective way; being the pharmacist, in regulative affairs, an entity responsible for this as a principal actor of medicine which must work as a whole with the Authority of Health and aligned to the pharmaceutical issue in force regulations. As a matter of fact, in this investigation, a general objective is set up to: elaborate a guide directed to pharmacists who work in regulative affairs, on the functions that it must fulfilled in the sanitary vigilance of medicines, so that they could coordinate, regulate, evaluate, monitor the medicines; to obtain result, the national and international existing related to the sanitary vigilance of medicines was checked. Besides, the activities and responsibilities of the pharmacist were developed in regulative affairs in each of the processes involved in the sanitary vigilance of medicines.