Pharmacovigilance requirements

The process of pharmacovigilence requires the contribution of many healthcare professionals in industry, government, and clinical practice. With improved harmonization, more sophisticated analysis tools, and clearer communication, more patients will be able to realize the benefits of drug therapy while minimizing the attendant risks. 

The requirements for pharmacovigilance systems in Europe are contained in Directive 2001/82/EC and Directive 2001/83/EC, and Regulation (EC) No. 726/ 2004, and supported by guidance extensive guidance set out in The Rules Governing Medicinal Products in the European Union, Volume 9, Pharmacovigilance. 

In the EU, a basic requirement for marketing authorisation holders (MAHs) is that they must have permanently and continuously at their disposal a nominated qualified person, with responsibility for pharmacovigilance. This person should have experience in all aspects of pharmacovigilance and, if not the holder of a medical or veterinary qualification, they should have access to such a person. The duties of the qualified person include ... 

Council Regulation EEC/2309/93 together with Directive 75/319/EEC require member states to establish a national pharmacovigilance system to collect and evaluate information on adverse reactions to medicinal products and to take appropriate action. 

CPMP Joint Pharmacovigilance Plan for the Implementation of the ICH E2B Ml and M2 Requirements Related to the Electronic Transmission of Individual Case Safety Reports in the Community. 

Article 102 includes a provision that requires Member States to share information collected through their pharmacovigilance system with other Member States and the EMEA. The central database EudraVigilance has been developed to allow Member States and the EMEA to share information on adverse drug reactions once all Member States have populated it. 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

This guideline lays down the requirements and procedures for national competent authorities regarding the collection, evaluation and management of pharmacovigilance data on medicinal products, however authorised in the community. 

The requirements for reporting adverse drug reactions to prescription medicines occurring in Australia or overseas are described in the Australian Pharmacovigilance Guidehne, which is available at the TGA website. 

All reports on suspected ADRs are co-ordinated and assessed in the company s Medical Department and/or Pharmacovigilance Unit. As much relevant information as possible is obtained from the doctor concerned to enable physicians and scientists to assess the case and determine whether the reaction was caused by the product. A special company ADR card which is often similar to the CSM yellow card may be sent to the doctor to be completed with the required details. 

An early study of pharmacovigilance [46] reported that the incidence of side effects was indeed low oropharyngeal itching represented about 50% of the untoward effects, followed by rhinorrhea and constipation. Urticaria and asthma were very rare. More than 90% of the effects were mild and did not require any kind of medical treatment. No systemic anaphylaxis was reported. 

In order to establish and maintain a pharmacovigilance system, the holder of the marketing authorization is required to have permanently and continuously at his or her disposal an appropriately qualified person. This qualified person is personally responsible for ensuring that information about all adverse reactions that are reported to the personnel of the company and to medical representatives is collected and collated. This qualified person is also responsible for ensuring that all suspected serious adverse reactions are reported to the competent authority concerned. 

Other, newly identified special populations result from pharmacovigilance signals, unexpected use of the product in an unanticipated population, requirements for regulatory filings in non-ICH nations, or even the spread of disease into new geographical areas. Traditional pharmacokinetic approaches are usually the first step in assessing whether these events will alter product efficacy or safety. 

Systems audits in pharmacovigilance are useful to evaluate all processes and SOPs related to pharmacovigilance and to assess the interaction with investigator sites, CRAs and related in-house personnel involved in handling safety information. QA auditors verify if the pathways and timeframes for reporting AEs and SAEs are followed and that all required recipients of such safety information are notified as needed (e.g. http //eudravigilance. emea.eu.int). SOPs and, if required, protocol-specific... 

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