Prefilled Syringes and Regulatory Landscape

Prefilled syringes were first launched in the 1970s and since then have undergone considerable changes. As such products continue to evolve each year, regulations and laws governing the various aspects of these devices, such as design, development, manufacturing, and approval, are also being improved. Moreover, these laws and regulations vary in different regions of the world. Prefilled syringes are considered as combination products rather than just container closure systems for small molecule drugs and biologics. Therefore, they are regulated under the provisions of pharmaceutical or device legislation around the world. Therefore, it becomes very important for prefilled syringe manufacturers to understand and develop the necessary expertise to comply to the regulatory environment of the target market(s) in order to achieve commercial success.

The regulatory environment for market authorization of prefilled syringes varies across different countries, such as the US, EU, Canada, Latin America (Brazil, Mexico and Argentina), Asia Pacific (Australia, Japan, China, India and South Korea) and the Middle East (Saudi Arabia and UAE). Amongst all the aforementioned countries, combination products are considered as separate product entities (in addition to drugs and devices) only in the US. They constitute a combination of any two or more medical products. Like all other medical products, combination products are also regulated by the FDA. In fact, a separate regulatory body, called the Office of Combination Products has been formed in the US to coordinate and streamline the regulatory life cycle of such combination products. According to the FDA, the products that are categorized as combination products include:

• Single entity, where two or more components are physically, chemically, or otherwise combined to produce a single entity.
• Co-packaging, where two or more separate entities are packaged together in a single package.
• Cross-labelling, where two or more components are packaged separately, but are intended to be used together or in combination for intended use, indication, or effect.

The FDA may apply drug or device regulations or both to regulate / approve a drug-device combination product. The agency follows certain guidelines to decide the regulations to be applied on a particular combination product and are handled on a case-by-case basis. However, an uncertainty on how to apply these regulations still remains. This is referred to as downstream issues.

In most of the above-mentioned countries, the approval pathway (either as drug or device) for the combination product is determined on the basis primary mode of action (PMOA). The PMOA for prefilled syringes is the therapeutic effect of the drug, therefore, in most of the countries such syringes are considered as medicinal products and are allocated to regulatory centers that review and approve drugs. However, in some countries, such as South Korea, India and Argentina, regulations related to combination products are not well defined.

Figure given below, summarizes the regulations related to prefilled syringes across different geographies. The report further features an informative summary of various guidelines established and issued by major regulatory bodies for the approval of prefilled syringes, across different countries / geographical regions.

Regulatory bodies: ANMAT: Administración Nacional de Medicamentos, Alimentosy Tecnología Médica; ANVISA: Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency); APSC: Administrative Processing Service Center; BGTD: Biologics and Genetic Therapies Directorate; CBER: Center for Biological Evaluation and Research; CDE: Center of Drug Evaluation; CDER: Center for Drug Evaluation and Research; CDRH: Center for Devices and Radiological Health; CFDA: China Food and Drug Administration; CDSCO: Central Drugs Standard Control Organization; CMDE: Center of Medical Device Evaluation; COFEPRIS: Comisión Federal para la Protección contra Riesgos Sanitarios; EMA: European Medicines Agency; MHLW: Ministry of Health, Labour and Welfare; MFDS: Ministry of Food and Drug Safety; NB: Notified Body; NCA: National Competent Authority; OCP: Office of Combination Products; PMDA: Pharmaceutical Medical Devices Agency; SFDA: Saudi Food and Drug Authority; TPCC: Therapeutic Products Classification Committee; TGA: Therapeutic Goods Administration; TPD: Therapeutic Products Directorate; USFDA: US Food and Drug Administration.

Note: In the EU, Conformité Européene (CE) mark is also required for approval of prefilled syringes

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