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What is a Post-Authorisation Safety Study?

The European Medicines Agency (EMA) requires a Post-Authorisation Safety Study (PASS) to be submitted after a pharmaceutical product has obtained approval. It is a study that is conducted, after receiving authorisation from EMA, to either collect more information on a product’s safety profile or to measure how effective the products risk management measures are. The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA evaluates the protocols and results of these studies. The information in a PASS helps to evaluated the safety profile of a pharmaceutical, with respect to its benefit-risk profile, and provide the necessary information for regulatory decisions. These studies can either be clinical trials or non-interventional studies.

The Directive 2001/83/EC for PASS defines one as a study that relates to “an authorised medicine product conducted with the aim of identifying, characterising, or quantifying a safety hazards, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.”

According to EMA, a PASS is determined as non-interventional if:

the pharmaceutical product is prescribed in the usual way in accordance with marketing authorisation terms.

decided the way of treatment I based on current practice- not a trial protocol.

the prescription of the pharmaceutical product is separate from the decision to include the patient in the study.

patients do not undergo additional diagnostic or monitoring processes.

epidemiological methods are used for data analysis.

There are 2 types of PASSs: imposed & voluntary.

Imposed PASS - These studies are mandatory for Marketing-Authorization Holders (MAH). They can be granted under exceptional circumstances, or PRAC may request companies to conduct them.

Voluntary PASS - Conducted without any regulatory obligation, these studies are initiated by MAHs to complement risk-management plans. They provide additional insights into the safety and efficacy of the medicine.

Regulation (EC) No 726/2004, Director 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 include the applicable provisions for PASS that are applicable in the European Union.

The ‘Good Pharmacovigilance Practices Module VIII- Post-authorisation safety studies’ covers interventional and non-interventional PASS, with a focus on non-interventional PASSs. Its aim is to provide marketing authorization holders (MAHs) with guidance on ensuring transparency and maintaining the scientific & quality standards of non-interventional PASS.

DDReg’s Capabilities

DDReg’s capabilities for PASSs are diverse and have catered to the unique requirements of its customers. The team has the capability to design protocols and manage PASS to ensure compliance with EMA. This includes development of protocol, data collection, data analysis, and reporting while adhering to stringent global pharmacovigilance standards. For PASS, the team closely coordinates with pharmaceutical companies and regulatory agencies with respect to risk management plans (RMPs) and periodic safety update reports (PSURs). They communicate with the competent authorities to efficiently and promptly address queries to ensure timely and successful PASS outcomes that maintain compliance and safeguard public health.

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