In today’s interconnected pharmaceutical world, ensuring drug safety is a non-negotiable global mandate. Pharmacovigilance Services (PV)—the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem—requires a nuanced, country-specific approach.
While the core mission remains patient safety, the regulatory frameworks, reporting systems, and local requirements vary drastically from one region to the next. For any pharmaceutical company with a global footprint, understanding and adhering to these diverse local requirements is the key to maintaining compliance and market access.
Here is a look at the essential pharmacovigilance requirements across five major global markets: the USA, UK, Japan, South Korea, and Indonesia.
1. USA: The FDA’s Two-Pronged Approach
The United States utilizes a multifaceted Pharmacovigilance and Drug Safety Service Provider in USA overseen by the Food and Drug Administration (FDA).
- Key Regulatory Systems:
- The FDA Adverse Event Report System (FAERS) handles post-marketing surveillance for pharmaceuticals and biological products.
- The Manufacturer and User Facility Device Experience (MAUDE) database tracks issues related to medical devices.
- Reporting Mechanism: While adverse drug reaction reporting is voluntary for healthcare professionals, consumers, and patients (typically via MedWatch), it is mandatory for manufacturers, distributors, importers, and IND reporters.
- Regulatory Focus: Emphasis on Risk Evaluation and Mitigation Strategies (REMS) and ensuring comprehensive safety data collection throughout the product lifecycle.
2. UK: Post-Brexit MHRA and the QPPV Mandate
The Medicines and Healthcare products Regulatory Agency (MHRA) is the central authority for pharmacovigilance Consultant in United Kingdom.
- Key Regulatory Requirement: A Marketing Authorisation Holder (MAH) must submit all necessary PV data, including UK and non-UK Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs), directly to the MHRA.
- The QPPV/NCPP Role: A critical compliance step is the requirement for a permanently and continuously available Qualified Person for Pharmacovigilance (QPPV). If the QPPV Services is not based in the UK, a National Contact Person for Pharmacovigilance (NCPP) must be appointed and based in the UK to handle immediate local inquiries.
3. Japan: The PMDA’s Three-Pillar System
In Japan, post-marketing surveillance is managed by the Pharmaceutical and Medical Device Agency (PMDA), working closely with the Ministry of Health, Labour and Welfare (MHLW).
- System Overview: Japan operates under a unique “three-pillar safety system” covering safety review, post-marketing safety measures, and relief services for adverse health effects.
- Reporting and Data: Adverse event information is collected in the Adverse Drug Reaction Database (ADR-DB). Reporting is voluntary for healthcare professionals and the general public, but mandatory for Marketing Authorization Holders (MAH), who can submit electronically. Japan is also implementing advanced techniques like data mining and sentinel institution networks for faster signal detection.
Pharmacovigilance Services in Japan
4. South Korea: KAERS and Mandatory Foreign Reporting
South Korea’s PV Services is managed by the Korea Institute of Drug Safety and Risk Management (KIDS), operating under the Ministry of Food and Drug Safety (MFDS).
- Reporting System: The centralized platform for adverse event reports is The Korea adverse event reporting system (KAERS).
- Key Features: Anyone can report, including the public, physicians, and Regional Pharmacovigilance Centres (RPVCs). Notably, reporting of foreign Adverse Drug Reactions (ADRs) is mandatory, allowing for a more comprehensive global view of product safety.
5. Indonesia: The Evolving System and the RPPV
As a nation with a rapidly evolving regulatory environment, Indonesia’s PV services are overseen by the Food and Drug Control Agency (Badan POM).
- Central Role: Badan POM functions as the National Centre of Pharmacovigilance, assessing the benefit-risk ratio of drugs and developing guidelines.
- Reporting Requirements: Reporting is voluntary for healthcare professionals and patients (using the Yellow form or online forms). However, it is mandatory for Marketing Authorization Holders (MAH) and manufacturers, who must use the CIOMS form.
- Personnel Requirement: Pharmaceutical companies are mandated to have designated pharmacovigilance units with a Responsible Person for Pharmacovigilance (RPPV).
Comprehensive Global Pharmacovigilance Services
Managing drug safety across these varied regulatory frameworks requires a robust, unified system. A comprehensive pharmacovigilance services portfolio is essential to ensure compliance and patient safety worldwide.
Such services typically include:
- ICSR Processing and Submission: Efficient triage, case processing through E2B(R3) compliant databases, and timely submission of Individual Case Safety Reports and SUSARs according to local agency timelines.
- PV Risk Management: Drafting and maintaining country-specific Risk Management Plans (RMPs) and implementing supplementary measures like Post-Authorization Safety Studies (PASS).
- Aggregate Reports: Authoring and submission of required reports, such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).
- PV Signal Management: Proactive identification, tracking, and analysis of new safety signals from ICSRs, literature, and regulatory sources, followed by recommendations for risk minimization and label updates.
- Local Responsible Person Services: Provision of required local personnel, such as the UK QPPV/NCPP, or the RPPV in Indonesia, to ensure local compliance and immediate regulatory contact.
- PV Audit & Compliance: Conducting compliance audits, gap assessments, and mock inspections to prepare organizations for regulatory scrutiny.
By partnering with experts who understand the intricate differences between the FDA’s FAERS system, the MHRA’s QPPV requirement, and Asia’s evolving platforms like KAERS and the PMDA’s ADR-DB, pharmaceutical companies can ensure patient safety remains paramount while successfully navigating the complexities of global drug regulation.