What is the Periodic Safety Update Report (PSUR)?
The Periodic Safety Update Report (PSUR) is described as a pharmacovigilance document that is intended to provide an evaluation of the risk-benefit balance of medicinal products at defined time points after their authorization. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and benefits. The fact is, pharmaceutical companies must identify and demonstrate the benefits and risks of medicine to obtain a marketing authorization. A medicinal product is only authorized if, at some point, the benefits of the medicine, which are provided in the form of MAA (Marketing Authorization Application) as assessed by the regulators, outweigh the risks. However, it is important to emphasize that this balance is valid at a certain point in time, but may change as the drug enters the market. This change in balance is influenced by many patient exposures, diseases, long-term effects, confusion factors, and uncontrolled conditions.
Preparation and submission of PSUR’s to EMA
The Marketing Authorization Holder is responsible for the submission of the PSURs for his products [Article 107b DIR] [Article 28 (2) of the REG]. Unless otherwise specified by the competent authorities, the marketing authorization holder shall prepare only one PSUR for all medicinal products containing the same active substance. It shall include information on all permitted indications, route of administration, dosage forms, and dosing regimen, regardless if the medicinal product is authorized under different names or separate procedures.
The PSUR should be submitted to the Agency (EMA) (VII.C.9 on transitional measures) within the following deadlines:
- within 70 calendar days of the data lock point (day 0) for PSURs covering intervals up to 12 months (including intervals of exactly 12 months);
- within 90 calendar days of the data lock point (day 0) for PSURs covering intervals over 12 months;
- the timeline for the submission of ad hoc PSURs requested by competent authorities will normally be specified in the request, otherwise, the ad hoc PSURs should be submitted within 90 calendar days of the data lock point.
Marketing authorization holders who registered their products centrally before 2012 July 2nd and by 2012 July 21st have authorized their products nationally and for which the frequency and dates of submission of PSURs are not specified as a condition of marketing authorization, shall submit PSURs according to the following timetable:
- Every 6 months with a marketing authorization granted, even if the product is not marketed;
- Once a product has been placed on the market, PSURs must be submitted twice a year after the initial placing on the EU market for 2 years, then once a year for the next 2 years, and every three years thereafter.
Generics, well established, homeopathic and herbal products are exempted from scheduled submission of PSURs unless otherwise required through the European Union reference date (EURD) list or specified in the marketing authorization. The MAHs of such medicinal products should use alternative mechanisms such as signal management and emerging safety issues channels to communicate relevant new safety information to regulatory authorities.
It is not uncommon for marketing authorization holders (MAHs) to face difficulties in submitting a PSUR for the first time. There is a need for excellent knowledge of existing regulatory acts, deadlines for submitting documents, and experience. At Insuvia we assist MAHs in the preparation and submission of PSURs to the European Medicines Agency and ensure professionalism at every step. By submitting a well-prepared PSUR, marketing authorization holders can be assured of the authorization of a medicinal product if it is not already authorized, as well as the efficient and rapid re-submission of a PSUR, thus saving time, resources and costs.
We also want to note that this review does not provide all the necessary information and aspects for the preparation and submission of PSURs.
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