Regulatory Affairs Overview

Regulatory Affairs (RA) Ensures compliance with laws, guidelines, and ethics for medicines, medical devices, and related items. Pharmaceutical Products Medicines, medical devices, cosmetics, and nutraceuticals regulated by RA. Medical Devices Instruments, apparatuses, machines used in healthcare for diagnosis, prevention, treatment. Orphan Medicines Treat rare diseases, have limited market appeal, may lack financial viability. Herbal Medicines Medicinal products derived from plants, used for therapeutic purposes. Vitamins Organic compounds essential for normal growth, metabolism, health maintenance. Nutraceuticals Products combining nutritional and pharmaceutical qualities, offer health benefits. Homoeopathic Medicines Alternative medicines based on the concept of 'like cures like'. Patient-Specific Medicines Tailored to individual patients' needs, not mass-produced. Unlicensed ('Specials') Medicines Prepared for specific patients under healthcare professional responsibility. Importing Unlicensed Medicines Bringing in medicines not authorized for sale in the country. Regulatory Approval Process leading to authorization for marketing a medicine. Medical Formulations Different designs of medicines based on formulation types. Anatomic Therapeutic Chemical (ATC) United Nations' coding system for medicines. Marketing Authorisation 1/5 Approval for marketing a medicine in a specific region. Pharmacy Nostrum Exemption allowing pharmacists to prepare medicines not regulated by EU law. Extemporaneous Prescriptions Pharmacies prepare medicines on-demand, not pre-manufactured. Sterile Manufacturing Cabinet Facility in pharmacies for sterile preparation of medicines. General Pharmaceutical Council Regulatory body overseeing pharmacies in Great Britain. Department of Health (NI) Responsible for pharmacy inspections in Northern Ireland. Pharmaceutical Society of Ireland Regulatory authority for pharmacies in the Irish Republic. Classifying Schemes in Healthcare Categorizing patients, diseases, body parts, and medicines for healthcare purposes. Tiers of Medicines Classification levels for medicines based on legal restrictions and authorizations. Development Sequence of Medicines Step-by-step process from research to market approval for a new medicine. Political Classification of Medicines Categorization based on political favoritism or neutrality towards certain medicines. Price Influence Factors affecting medicine pricing, including government, patients, and healthcare providers. Organisational Concepts Structural ideas influencing the pharmaceutical industry, like potency and global ranking systems. Potency Strength or effectiveness of a drug, especially for intermittent use. MHRA Regulatory body for human treatments in Britain 2/5 VMD Regulatory body for animal treatments in Britain Nostrum Rules EU pharmacist laws governing small-scale medicine preparation GPhC Inspectors who can visit pharmacies for enforcement Special Batches Small formulations prepared by retail pharmacies Rx Prescription-based medicines in retail pharmacies OTC Over-the-counter medicines in retail pharmacies Specials One-off small batch medicines made outside registered pharmacies Manufacturer's Licence Required for 'specials' firms by the MHRA Qualified Person (QP) Not needed for 'specials' release approval by a pharmacist Veterinary Medicines Regulations 2007 Replaced a fundamental law for manufacturing animal medicines Orphan Drug Legislation Introduced by the US FDA in 1999 and EC in 2003 Traditional Herbal Medicines Registra- Allows approval based on traditional use tion Scheme and safety standards Section 12(1) of the 1968 Medicines Act Allows sale of herbal remedies without specific qualifications St John's Wort Example of herb with different regulations across Europe Medical Device Definition Legal definition in Europe; includes instruments, software, materials for human use. Excluded Medical Devices Items acting pharmacodynamically, immunologically, or metabolically. 3/5 Notified Body (NB) Commercial firm assessing and approving medical device applications in EEA. Medical Device Classification Categorized based on risk, role, place of use, re-usability, among other factors. Class I Medical Device Low-risk devices like scalpels, bandages, and tongue depressors. Class II Medical Device Medium-risk devices without power, including x-ray images. Class III Medical Device High-risk devices like artificial organs, intra-uterine devices, and genetic engineering systems. CE Number Assigned to medical devices for market access in the EEA. In Vitro Diagnostic Medical Devices (IVDs) Devices not used on patients, like pregnancy testing kits. Control of Devices vs. Medicines Device regulation softer compared to medicines, especially in severity of control. Regulatory Bodies Entities overseeing medical device use in humans, lacking control in veterinary settings. IVD vs. Conventional Device IVDs do not directly or indirectly touch patients, unlike conventional devices. European vs. FDA Categories Distinction between European and FDA device categorization. Inherent Problems in Device Approval System Challenges in the single Notified Body approval process within the EEA. Soft Control of Devices Comparison of device regulation leniency to that of medicines. CE Number Usage Printed on devices for EEA market access, with language-specific instructions. IVD Definition 4/5 Directive 98/79/EC defines In Vitro Diagnostic Medical Devices separately. Device Legislation Scope Laws affecting human device use, lacking veterinary device control. Bibliography Importance Varied websites relevant to regulatory aspects in the medical field. Obsolete RA Books Warning about the outdated nature of most regulatory affairs books. Notified Body Approval Process NB assesses, classifies, and approves medical device applications in the EEA. Device Classification Guidelines Detailed rules for classifying devices based on various factors. Class Im Medical Device Low-risk devices with a measuring function, like a tidal breath volume measurer. National Competent Authorities Entities controlling and approving Notified Bodies within EEA member states. Soft Device Control Comparison Contrast in regulatory strictness between devices and medicines. IVD vs. Conventional Device Example Distinguishing between In Vitro Diagnostic Devices and conventional devices. Device Legislation Limitation Lack of laws regulating veterinary device use in most countries. Regulatory Bodies Overview Entities overseeing human medical device use with limited veterinary control. Device Regulation Leniency Comparison of regulatory softness between devices and medicines. 5/5