
Medical devices in the composition of drugs from the regulatory affairs specialist point of view
Every year in Moscow a scientific and practical conference RegLek is organized. This is a huge event aimed at covering many issues regarding the development and provision of registration dossier materials, their examination and subsequent work on the comments and recommendations of the regulator.
Many issues at the conference were considered not only in terms of EAEU legislation, but also EMA and FDA regulation, which made it possible to obtain a more complete picture on the issue of interest. In particular, the presentation on medical devices (MD) combined with a drug and the logic of regulators in different countries when conducting examinations of such products aroused particular interest.
Thus, in the USA, a product consisting of a drug + MD is sent for examination to one or another department, depending on what determines the main effect of the product (drug or MD in the composition). For example, if the “leading” component in the product is a drug, then the dossier for examination will be sent to The Center for Drug Evaluation and Research (CDER), since in this case the area of expertise of this unit will “cover” the main effect of the product. In addition, preliminary consultations on the development and registration of such products are possible in the United States.
In the EU, medicinal products containing MD in their packaging undergo examination by the department responsible for drug registration. In this case, the registration file for such a drug must contain information about the status of the medical device in the EU (CE certificate of conformity depending on the risk class) or supporting documents and data in the registration file on the compliance of the medical device with legal requirements.
In the EAEU there is no classification or types of MD that can be combined with drugs and vice versa. In this regard, there are no clear recommendations for applicants regarding the expert organization that is authorized to conduct the examination. In this case, the following approach to registration of such combined products is recommended:
1) Registration of medical devices separately from drugs according to the requirements of the EAEU.
2) Registration of a drug in combination with medical device.
It is important that drugs cannot be registered with medical devices approved according to the national procedure.
However, there are also those MDs that do not require separate pre-registration. According to EAEC recommendation No. 25, these include:
- primary, intermediate and secondary (consumer) packaging of a drug, including the primary packaging of the medicinal product, which is a means of administration (for example, a multi-dose syringe pen with a built-in non-removable cartridge, a pre-filled syringe);
- a dosing device (dispenser) and (or) a device for dissolving (diluting) the drug (for example, an adapter, dosing syringe, dosing cap, dosing spoon), included in the secondary (consumer) packaging of the medicinal product;
- sachets or tablets with a desiccant included in the primary or secondary (consumer) packaging of a drug.