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During the 1990’s, the deaths of two healthy volunteers in the US made their way to the highest political levels and forced a review of protection of human subjects. Ellen Roche 24 year old Healthy Volunteer Asthma study Jesse Gelsing er 18 year old Healthy Volunteer Genetic Study
In March of 1994, the U.S. Office of Research Integrity announced that Dr. Roger Poisson from Montreal admitted having falsified data (99 cases) in a breast cancer clinical trial sponsored by the U.S. National Cancer Institute (NCI). This well-intended falsification compromised the contribution of hundreds of women enrolled in the protocol as all data from the 389 patients enrolled by Dr Poisson were removed from the analysis. Dr. Roger Poisson
Article 106 of Directive 2001/83/EC and Article 26 of Regulation (EC) No 726/2004 specifically requires the European Commission in consultation with the European Medicines Agency (EMEA – “the Agency”), Member States and interested parties to draw up guidance on the collection, verification and presentation of adverse reaction reports in order to facilitate the exchange of information about human pharmacovigilance within the Community.
The pharmacovigilance obligations apply to all medicinal products authorised in the EU.
Ensure that an appropriate system of pharmacovigilance is in place in order to assume responsibility and liability for his products on the market and to ensure that appropriate action may be taken when necessary.
Report all information relevant to the risk-benefit balance of a medicinal product to the Competent Authorities and the Agency fully and promptly in accordance with the legislation.
Should have permanently and continuously available a Qualified Person Responsible for Pharmacovigilance, residing in the EU.
The Marketing Authorisation Holder should ensure that the QPPV has sufficient authority
To implement changes to the MAH’s PV system in order to promote, maintain and improve compliance; and
To provide input into Risk Management Plans and into the preparation of regulatory action in response to emerging safety concerns.
The Marketing Authorisation Holder should assess risks with potential impact on the pharmacovigilance system.
A Marketing Authorisation Holder may transfer any or all of the pharmacovigilance tasks and functions, including the role of the QPPV, to another person(s) or organisation. In such cases, clear documented contractual agreement for meeting PV obligations should be in place between the parties involved.
Periodic Safety Update Report (PSUR) - an update of the worldwide safety experience of a medicinal product to Competent Authorities at defined time points post-authorisation
Summary Information & critical evaluation of all the relevant new safety data from the appropriate sources
Once a medicinal product is authorised in the EU, even if it is not marketed, the Marketing Authorisation Holder is required to submit PSURs at 6-monthly intervals.
Once marketed, 6-monthly PSUR submissions should be continued following initial placing on the market in the EU and until two full years of marketing experience in the EU has been gained. Then, PSURs should be submitted once a year for the following two years and thereafter at 3-yearly intervals.
Both the Marketing Authorisation Holder and the Competent Authorities must keep abreast of all relevant information in order to fulfil the following responsibilities:
Ensuring that all sources of information are screened regularly to identify any potential signals;
Ensuring that appropriate action is taken in response to new evidence which impacts on the known risk-benefit balance;
Variation of marketing authorisation
Provision of important safety information to Healthcare Professionals and Patients.
If the safety concerns require urgent action, the MAH should initiate an urgent safety restriction followed by variation filing.
Product withdrawal from the market should be discussed with all the concerned competent authorities before communication to the public.
Part II – Undertaking of PV activity by Competent Authorities and the Agency
Each Member State should monitor Marketing Authorisation Holder compliance with PV obligations and should undertake PV inspections.
Each Member State should have in place systems for receipt and evaluation of all pharmacovigilance data and to ensure that appropriate regulatory action may be taken.
For centrally authorised products, the European Commission is the Competent Authority. The responsibility for the conduct of pharmacovigilance of any MRP or DCP product rests with the Competent Authorities of all individual Member States who have granted the authorisation.
Competent authorities should ensure that appropriate and timely information is provided to WHO and other international bodies.
Rapid Alert and Non-Urgent Information System in Pharmacovigilance
During the marketing period of a medicinal product, urgent measures to safeguard public health may be necessary.
Information regarding safety concerns, particularly those which may result in major changes to the marketing authorisation status or revocation or withdrawal of a product, is exchanged between the Member States, the Agency and the European Commission with the appropriate degree of urgency.
Rapid Alert (RA) / Non-Urgent Information (NUI)
Part III – Electronic exchange of PV information in the EU
Provides reference to the electronic transmission of ICSRs
Applies to national Competent Authorities, the European Medicines Agency and Marketing Authorisation Holders in the EU.
EU legislation (EC) No. 726/2004, Article 24(2) and Directive 2001/83/EC, recital 56 and Article 104(1)
EudraVigilance – European pharmacovigilance database and data-processing network
Part IV – Direct Healthcare Professional Communications
Information aimed at ensuring safe & effective use of medicinal products which is delivered directly to Healthcare Professionals by a MAH or Competent Authority.
Dissemination is usually required in following situations:
Suspension / Withdrawal of marketing authorisation
Important Changes to the Summary of Product Characteristics
Change in the risk-benefit balance of the drug
Availability of new recommendations for treating adverse reactions
The Competent Authorities are those who have issued a marketing authorisation for the medicinal product concerned.