grr japan pptx
TRANSCRIPT
Drug Regulatory Agencies In JAPAN
Presented by- Co-Presented by-Namrata Mange Sulabh SinghaniaM.Pharm – 2nd SEM M.Pharm- 2nd SEM
DEPARTMENT OF PHARMACEUTICS
E.No:-201504100410005 E.No:- 201504100410019
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Drug regulatory agency of Japan
• Ministry Of Health, Labour And Welfare (MHLW )
• Pharmaceutical and Medical devices Agency(PMDA)
PMDA
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Pharmaceutical and Medical devices Agency (PMDA)
• PMDA continues to improve the public health and safety of
Japan by reviewing applications for marketing approval of
pharmaceuticals and medical devices, conducting safety
measures, and providing relief to people who have suffered
from adverse drug reactions.
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Principle • They make science-based judgments on quality, safety, and
efficacy of medical products by training personnel to have the latest technical knowledge and wisdom in their field of expertise.
• They play an active role within the international community by promoting international harmonization.
• They conduct services in a way that is trusted by the public based on our experiences from the past.
• They will be the bridge between the patients and their wishes for faster access to safer and more effective drugs and medical devices.
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Who is PMDA• PMDA (Pharmaceuticals and Medical Devices Agency) is
Japanese regulatory agency, working together with Ministry of Health, Labor and Welfare.
• Their obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
• They conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety.
• They are also responsible for providing relief compensation
for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
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History • Following the Reorganization and Rationalization Plan for Special
Public Corporations that was approved in a Cabinet meeting in 2001, the Pharmaceuticals and Medical Devices Agency (PMDA) was established and came into service on April 1, 2004, under the Law for the Pharmaceuticals and Medical Devices Agency.
• As a consolidation of the services of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and part of the Japan Association for the Advancement of Medical Equipment (JAAME).
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Regulations and Services
Post-marketing Safety Measures
• We collect safety information, such as adverse drug reactions, infections caused by use of pharmaceuticals and medical devices and adverse events caused by medical devices from companies and healthcare professionals. That information is stored into a database for scientific analysis and investigation. Findings from investigation are reported to the MHLW, which would result in administrative actions to ensure safety use of pharmaceuticals and medical devices, etc.
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• We provide information on pharmaceuticals and medical devices on the website in order to promote their proper use, by listing package inserts, product recalls, drug guide for patients and other urgent safety alerts as well as reports on adverse drug reactions and adverse events of medical devices submitted to the PMDA from companies.
• We also offer free e-mail information delivery services providing latest safety information to the health care professionals.
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• We provide telephone consultation services on pharmaceuticals and medical devices for consumers, etc.
• We collect safety measure contributions from marketing authorization holders of pharmaceuticals and medical devices.
• We develop and implement new methods and techniques for post-marketing safety operations, such as data mining method and sentinel medical institution network, with a view to enhancing quick response to problems and taking accurate safety measures. Thus it enables us to prevent and predict safety problems.
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Risk Management Plan
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Relief Services for Adverse Health Effects
• We have "Adverse Drug Reaction Relief System" to compensate for death or health damages requiring hospitalization, caused by appropriately used prescribed and purchased drugs.
• We have "Relief System for Infections Derived from Biological Products" to compensate death, health damages requiring hospitalization caused by infections from appropriately used biological products.
• We provide "Healthcare Allowance" to SMON patients under the commission of Japanese government and pharmaceutical companies.
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• We also provide "Healthcare Allowance" to HIV-positive and AIDS patients under the commission of the Yu-ai Welfare Foundation.
• We provide compensations in accordance with "the Special Measures Law concerning the Payment of Benefits to Relieve the Patients of Hepatitis C Infected through Specified Fibrinogen Preparations and Specified Blood-Coagulation Factor IX Preparations Contaminated by Hepatitis C Virus."
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Drug and Medical Device Reviews
• Scientific reviews of pharmaceuticals and medical devices for marketing authorization based on the Pharmaceutical Affairs Law of Japan
• Consultation (Planning and implementation of clinical trials and preparation of NDA dossiers, etc.) - GCP / GLP / GPSP inspections and conformity audit on dossiers submitted as initial application, re-examination and re-evaluation application
• GMP / QMS inspections on manufacturing sites, processes and quality management system of pharmaceuticals and medical devices
• Confirmation of re-examination and re-evaluations based on the Pharmaceutical Affairs Law
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GLP / GCP / GPSP Compliance Assessments
• PMDA conducts inspections and data integrity assessments in relation to applications for marketing approval, re-examination, re-evaluation, or use-results evaluation of a product to assess whether the tests and clinical trials have been conducted in an ethically and scientifically appropriate way.
• In compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Post-Marketing Surveillance Practice (GPMSP) or Good Post-marketing Study Practice (GPSP), and whether the submitted data comply with the data integrity standards for regulatory submission documentation.PMDA also provides GLP compliance certification to testing laboratories
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GMP / QMS / GCTP Inspections
• GMP inspection– For GMP inspection, PMDA conducts on-site and document-
based inspections of manufacturing sites for products classified as “high-risk,” such as new drugs, biological products or biotechnological products (including foreign manufacturing sites), in order to ascertain whether their manufacturing facilities and manufacturing and quality controls comply with standards such as the Good Manufacturing Practice (GMP), and whether the manufacturing sites have a system for manufacturing products of adequate quality.
PMDA also conducts inspections in relation to accreditation of foreign manufacturers.
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QMS inspection
• For medical devices and in vitro diagnostics, PMDA conducts on-site and document-based inspections of the registered manufacturing sites (of products under review or approved products) located in Japan or overseas, in order to ascertain whether their manufacturing facilities and manufacturing and quality controls comply with standards.
• Such as the Quality Management System (QMS), and whether the manufacturing sites have a system for manufacturing products of adequate quality.
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GCTP inspection
• PMDA has established a system to inspect manufacturing sites of cellular and tissue-based products located in Japan or overseas, in order to determine whether their manufacturing facilities as well as manufacturing process and quality management system comply with the Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP).
• PMDA has also developed a necessary system for inspections on compliance with the standards for buildings and facilities, and for-cause inspections and questioning for cell processing facilities, which will be newly started by the enforcement of the Act on Securing Safety of Regenerative Medicine.
Ministry of Health, Labour and Welfare
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History
• The MHLW, which was originally established in 1938, has been in charge of the improvement and promotion of social welfare, social security and public health.
• The ministry proper includes the Minister's Secretariat, 11 bureaus, and the Director-General for Policy Planning and Evaluation.
• It handles clinical studies, approval reviews and post-marketing safety measures, i.e., approvals and licensing.
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Conti…
• Closely related to the people’s lives-from birth to employment to the security of old age.
• Its activities encompass various phases of life such as medical services, public health, working environment, employment security, human resources development, child care, long-term Care, welfare and pensions.
• It is committed to the development of policies that will bring “security” and “activity ”to people’s daily lives.
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Functions of MHLW
• Social Welfare : • Social Security :• Human Resources Development : • Public Hygiene : • Job Security :• Working Environment :
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Names of Ministry of Health, Labour and Welfare Organizations
(1)Minister‘s Secretariat(2)Pharmaceutical & Food Safety Bureau
(3)Health Policy Bureau
(4)Health Service Bureau(5)Worker's Compensation Department(6)Industrial Safety and Health Department(7)Employment Security Bureau
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Conti….
(8)Social Welfare and War Victims' Relief Bureau(9)Human Resource Development Bureau(10)Health and Welfare Bureau for the Elderly(11)Health Insurance Bureau(12)Pension Bureau(13)Social Insurance Agency (14)Central Labour Relations Commission
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Pharmaceutical and Food Safety Bureau Functions• The work of this Bureau involves Controlling the
production and sales of drugs,cosmetics and medical devices, and collecting/offering information on adverse reactions from products in order to ensure effectiveness and safety.
• It also contributes to the healthy life of society by controlling narcotics stimulant abuse and ensuring chemical safety.
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Health Policy Bureau
Functions • The Health Policy Bureau works to plan and design
medical policy that will ensure that qualified and effective medical services are available for people suffering from disease or injury.
• It also supports research and development and industries in the field of medical supplies and medical devices .
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Health Service Bureau
Functions• The Health Service Bureau promotes local health-care
through health centers. It is working to control infectious diseases (Fever,Aids,tuberculosis,etc),lifestyle-related diseases (cancers, diabetes,etc),and other areas such as incurable diseases,allergies,as well as the deployment of appropriate organ transplantations.
• It also works to ensure that people are able to lead hygienic and comfortable lives .
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Workers’ Compensation Department
Functions• This Department is working to support workers and
bereaved families who have been the victims of industrial accidents by offering them immediate compensation.
• It is also enforcing the general rehabilitation plan for workers who have suffered industrial accidents and providing nursing care-centres for those workers seriously injured at work.
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Industrial Safety and Health Department
Functions• In order to ensure a working environment which is
safe and healthy.• The Industrial Safety and Health Department is
deploying the industrial accident prevention plan. • It is also working to prevent occupational diseases
and to promote healthy working environments for all worker.
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Employment Security Bureau
Functions• It mainly do reemployment of worker, employment
creation in the newly born industries and to bridge the gap between supply and demand in the labour market.
• These measures will relieve people’s anxieties about future unemployment, and again create a society with hope and vitality.
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Social Welfare and War Victims’ Relief Bureau
Function• This Bureau is working towards the planning and
managing the basic systems common in each area of social welfare including the social welfare foundation system, welfare offices, community chests, securing human resources for social welfare
• Its public assistance services are wide-ranging and include the planning and management of the welfare system.
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Human Resources Development Bureau
Function • This Bureau is implementing the human resources
development policies which deal with changes in the industrial structure brought about by the introduction of IT,changes in economic and social trends such as the diversification in working styles.
• It also aims to secure employment opportunities through the promotion of human resources development undertaken by workers themselves,supporting training programs conducted by employers.
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Health and Welfare Bureau for the Elderly
Functions• In order to help elderly people lead an independent,
dignified lives and to participate in social activities in an aging society.
• This Bureau manages the smooth implementation of the long-term care insurance system.
• It is also working to implement the provisions contained in “Long-Term Insurance Project and promoting various projects for elderly people to help them obtain a high quality of life.
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Health Insurance Bureau
function• The Health Insurance Bureau’s work includes the planning
and establishing of various medical insurance systems such as Employees’ Health Insurance, National Health Insurance, and Health Insurance System for the Latter-Stage Elderly.
Pension Bureau function• The Pension Bureau is working to establish and operate a
sustainable pension system that is truly trusted by people and which contributes to the security of people’s lives by planning for and operating a public pension system that supports the post-retirement lives of the people
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Thank you…