Regulatory affairs for Pharmacists and industry related professions only.
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Regulatory pharmacists in the private and public sectors work towards securing all government related regulations are in place for the pharmaceutical and other health related practices (medical devices, cosmetics, etc). The pharmacists in the industry are involved in all stages of development of the drugs until they are marketed to the public. Their knowledge and understanding have the highest regard in the pharmaceutical sciences. The responsibility of obtaining authorization of medicines for use in clinical trials, subsequently for registration and marketing and then post-approval surveillance activities such as safety updates, licensing applications for prescribing information, new clinical uses or new formulations, etc. It is in their hand that they are able to link the company (pharma, medical device, etc.) and the local regulatory authorities (FDA, DOH, etc) on matters relating to the quality, safety and efficacy issues of drugs. Pharmacists also work in areas such as pharmacovigilance, GMP audit and drug enforcement to ensure safety, efficacy and quality of pharmaceuticals and related products in the Philippines.
The Philippine FDA has called to amend the FDA Memorandum Circular (FMC) 2013-004 that aims to authorize Lawyers as Legal Representatives and Qualified Person in Industry (Food, Drug, Cosmetics, and Devices) Regulatory Affairs and Imposing Sanctions to QPIRAs for Violation of Part IV of FMC No 213-004 and Other Similar Violations.
This call to amend such FMC is going to be a threat to the employment and careers of fellow Pharmacists and other professionals who are in the Regulatory Affairs industry. Lawyers can serve as Legal Representatives however permitting them to become QPIRA is undermining the capability of a Pharmacist and causing damage to the morale of the Professional.
May this serve as a petition not to allow Lawyers to become QPIRAs. Pharmacists and other regulatory professionals are more than capable of doing the QPIRA job. We would like to ask the support of all pharmacists and other professionals in the Regulatory Affairs.
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