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Regulatory Services in Japan
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Regulatory Services in South AfricaPharmacovigilance Services in Japan
In Japan, the Pharmaceutical and Medical Device Agency (PMDA) which works alongside the Ministry of Health and Labour welfare (MHLW) oversees post-marketing surveillance of medicinal products and medical devices, and takes appropriate safety measures with the help of their unique three-pillar safety system which covers safety review of the medicinal product, post-marketing safety measures, and relief services for adverse health effects. Reporting of adverse events in Japan is voluntary and can be reported by healthcare professionals via email, fax, and post, the general public can report through the website, and marketing authorizing holders (MAH) can report via electronic transmission, post, or over the counter. All this safety information including adverse drug reactions and infections caused by medicines or medical devices is collected and stored in the adverse drug reaction database (ADR-DB). Further, the scientific analysis of this data is conducted to investigate the causal relationship and the report of this investigation is then submitted to the MHLW to take further actions to safeguard the use of pharmaceuticals and medical devices. Recently, Japan has been implementing new techniques such as data mining methods and sentinel institution networks for accurate and quick responses to the problems to prevent as well as predict safety concerns. Furthermore, information on the proper usage of medicines and medical devices is available on the website for patient use.
AAs a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Japan that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.
DDReg pharmacovigilance Services portfolio include:
ICSR Processing and Submission
- Triage of initial and follow-up ICSRs, SUSARs,
- Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
- Quality Check, Medical reviews
- Submission of cases as per agency timelines
- Maintaining ICSR monitoring & tracking sheets
- Reconciliation process with customers
Risk Management Plan
- Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
- Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
- Assessment of potential risks and missing information and prepare reports that recommend risk management methods
- Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
- Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)
Aggregate Reports
- Periodic Safety Update Report (PSURs)
- Periodic Safety Update Report (PSURs)
- Development Safety Update Reports (DSURs)
- Annual Safety Reports (ASRs)
Signal Management
- Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports as well as regulatory agency website monitoring.
- Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
- Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
- Performs label update analysis
- Provide recommendations from signal assessments which include risk minimization approaches
- Preparation of Signal Management Tracker, Annual Signal Reports.
QPPV Services
- Authoring & Review of PSMF, PV SOPs etc.
- Monthly reconciliation
- Medical review of Signal detection; Signal Surveillance Meetings (Quarterly)
- Monthly Communication report/provision of compliance metrics
- PV Quality Management System Oversight
PV Audit & Compliance
- Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
- Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
- Conduct regular gap assessments of PV staff at site location
- Provide organizational training on safety audits and inspections
Country Specific Services
- Regulatory Strategies / Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- Regulatory Services in India
- Regulatory Services in Mexico
- Regulatory Services in USA
- Regulatory Services in Canada
- Regulatory Services in Malaysia
- Regulatory Services in Singapore
- Regulatory Services in China
- Regulatory Services in Indonesia
- Regulatory Services in Philippines
- Regulatory Services in Vietnam
- Regulatory Services in Morocco
- Regulatory Services in UAE
- Regulatory Services in Kenya
- Regulatory Services in Turkey
- Regulatory Services in Saudi Arabia
- Regulatory Services in Jordan
- Regulatory Services in Egypt
- Regulatory Services in Colombia
- Regulatory Services in Japan
- Regulatory Services in South Korea
- Regulatory Services in South Africa
- Regulatory Services in Kazakhstan
- Regulatory Services in Italy
- Regulatory Services in Latvia
- Regulatory Services in UK
- Regulatory Services in Belgium
- Regulatory Services in Spain
- Regulatory Services in Australia
- Aggregate Reports
- Literature Monitoring
- Risk Management
- ICSR Processing & Submission
- Signal Management
- Audit and Compliance
- QPPV Services
- Pharmacovigilance Services in Mexico
- Pharmacovigilance Services in USA
- Pharmacovigilance Services in Canada
- Pharmacovigilance Services in Malaysia
- Pharmacovigilance services in Singapore
- Pharmacovigilance Services in India
- Pharmacovigilance Services in China
- Pharmacovigilance Services in Indonesia
- Pharmacovigilance Services in Philippines
- Pharmacovigilance Services in Vietnam
- Pharmacovigilance Services in Morocco
- Pharmacovigilance Services in Kenya
- Pharmacovigilance Services in Turkey
- Pharmacovigilance services in Saudi Arabia
- Pharmacovigilance Services in Jordan
- Pharmacovigilance Services in Egypt
- Pharmacovigilance Services in Japan
- Pharmacovigilance services in South Korea
- Pharmacovigilance Services in South Africa
- Pharmacovigilance Services in Kazakhstan
- Pharmacovigilance Services in Australia
- Pharmacovigilance services in UAE
- Pharmacovigilance Services in Colombia
- Pharmacovigilance services in Italy
- Pharmacovigilance services in Latvia
- Pharmacovigilance services in Belgium
- Pharmacovigilance services in Spain
- Pharmacovigilance services in UK
- DDReg's Publishing services
- DDReg's Medical Writing services
