Essay On What Is The Difference Between A Mutual Recognition Procedure And A Decentralized Procedure?

“The Decentralised and Mutual Recognition procedures are European authorisation procedures based on the principle of recognition of the assessment by the Reference Member State (RMS)” ( cbg-meb.nl). Mutual recognition procedures occur when a company has already approved the marketing plan in the reference member state and is now requesting the recognition of other states for the purpose of marketing authorization. It is usually a simple procedure unless the other member states are significantly concerned about the safety of a specific drug.
The decentralized procedure is attempted when a marketing plan has not yet been approved in any member state and the company wants the plan approved in multiple states at once. “After 70 days the RMS circulates the first Draft assessment report. On the 120th day of the assessment procedure, the RMS circulates another Draft assessment reportThere is also a Mutual Recognition Procedure during the next 90 days, in which other Member States generally adopt the RMS's” ( cbg-meb.nl).
The difference between the two procedures is that the mutual recognition procedure is done when the marketing plan has already been approved by the reference state while the decentralized procedure is undertaken when the plan has never been approved and the firm wants it approved in multiple member states across Europe at once.
What does an RMP stand for and why would this be an important tool for regulators in ensuring drug product safety?
RMP stands for risk management plan and these plans are often required by regulating agencies such as the European medicine agency and the U.S. food and drug administration before approval of a drug. The Pfizer website states that “This type of plan, or system, may be defined as a set of pharmacovigilance activities designed to identify, characterize, prevent, or minimize risks related to the medicine; to assess the effectiveness of those interventions; and to communicate those risks to patients and health care providers”. In Europe a pharmaceutical company most often has to have one of these plans written up and approved in order for the medicine to be approved for marketing and sale.
These plans are tools that further educate the EMA before it makes a decision regarding drug approval. The plan goes into depth concerning the studies done along with the standards and procedures used during the testing phase. This plan becomes a basis that helps promote risk minimization by clearly identifying all common and uncommon risks associated with the drug along with any weaknesses in the testing of it.
3) What is an EPAR? What is an SmPC? What is their link to the marketing authorization?
EPAR stands for European Public Assessment Reports. According to the European Medicines agency website “The EMA publishes an EPAR for every medicine granted a central marketing authorization by the European Commission following an assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). EPARs are full scientific assessment reports of medicines authorized at a European Union level.” These reports are done to track the safety and reliability of medications. The EPAR is done in correspondence with the EMA assessment of a drug and a summary of the findings are released to the public when the committee approves or disapproves the request for the drug to be brought to market.
The SMPC is the Summary of Product Characteristics and according to the European Commission it “must be included in the application “In accordance with Directive 2001/83/EC, when the marketing authorization is issued, the Marketing Authorization Holder shall be informed, by the competent authorities of the Member States concerned, of the SmPC as approved by it”. The SMPC is another contributing factor to the EMA’s decision of whether or not to approve the drug for sale to member states.
4) Explain the difference between conditional approval and exceptional circumstances. Provide a scenario wherein one or the other would be used.
EMA provides two tracks to expedite the approval of certain drugs under certain circumstances for the good of the public. In the case of approval under exceptional circumstances the EMA states that “in exceptional circumstances and following consultation with the applicant, the authorization may be granted This authorization may be granted only for objective, verifiable reasons and must be based on one of the grounds set out in Annex I to Directive 2001/83/EC, as amended. Continuation of the authorization shall be linked to the annual reassessment of these conditions.”
In contrast conditional approval is a temporary marketing approval that must be renewed and is under more restrictions and certain steps must be taken while the drug is in this stage. The EMA states that “Conditional marketing authorisations are valid for one year, on a renewable basis. The holder will be required to complete ongoing studies or to conduct new studies with a view to confirming that the benefit-risk balance is positive. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.”
Consider a case in which a new strain of the flu is displaying high mortality rates in patients with no approved drugs successfully negating the effects of the virus. Under these circumstances a new drug that shows promise may receive an approval filed under exceptional circumstances.
5) Two key objectives of global clinical trials are homogeneity and quality; explain what you understand about why these two concepts are important and provide examples of how they can be achieved. You may want to use the E5 and bioethics discussion to address this question.
Global clinical trials have a variety of benefits to both the world and the pharmaceutical companies themselves. Homogeneity is an objective of globalizing clinical trials because it allows the trials to include people from many different walks of life in many different environments. For example clinical trials are done in developing countries to make sure that the drug has the same effect on all patients regardless of ethnicity or environmental factors. High quality trials can be achieved by the national drug approval organizations creating a set of global standards by which companies must abide when conducting trials in the developing world. In addition it is also less expensive for the trials to be conducted in developing countries before trying to receive approval from the FDA or EMA.
However it is also important to consider the ethical dilemmas that can be associated with large pharmaceutical companies conducting trials in developing nations. According to the Pfizer website “Global pharmaceutical companies including Pfizer are doing increasing number of trials at sites in the developing world, in addition to sites in wealthy countries every trial – regardless of where it is conducted – must meet our Company Policies and international standards” Companies have to consider the culture of the nation as well as how to ethically conduct the study in a nation where more volunteers are likely to be living below the poverty line. References
"Pfizer: One of the World's Premier Biopharmaceutical Companies." Pfizer: One of the World's Premier Biopharmaceutical Companies. N.p., n.d. Web. 16 Mar. 2015.
Www.ema.europa.eu. N.p., n.d. Web. 16 Mar. 2015
"Official Website of the European Commission - Please Choose a Language." European Commission. N.p., n.d. Web. 16 Mar. 2015.
"Marketing Authorisation via Decentralised and Mutual Recognition Procedures." CBG-MEB. N.p., n.d. Web. 16 Mar. 2015