The Saudi Food & Drug Authority, the agency responsible for medical device regulation in the Kingdom of Saudi Arabia, issued draft guidance dedicated to the classification of the combination products. The document will be available for public comments since the agency expects to receive feedback from industry representatives to use this information for the purpose of improvement of the existing regulatory framework.
Combination Products: Guidance Definition
The document is intended to assist the industry representatives that are applying for the registration of combination products in familiarizing themselves with the classification rules and principles. It is also intended to provide them with the full scope of information related to appropriate submissions. In particular, the document gives the definition of the combination products and describes the way existing regulations should be applied.
According to the general rule, the class of the product should be initially defined by the company itself. At the same time, if the company faces certain difficulties regarding correct classification of the product it is going to supply, it could use the electronic Products Classification System (e-PCS) to file a request to the authority. The request should be properly supplemented with the documents needed for the authority to review it and make a reasonable decision. The agency is also entitled to require an applicant to provide any additional information other than what is specified in the guidance if it is found reasonably necessary. It is also stated that the authority reserves significant flexibility in the decision-making process, but in general, the decision would be made in accordance with the present document.
First of all, the document provides the list and explanations of the most important definitions, namely:
- Human cells, tissues, or cellular or tissue-based products (HCT/Ps) – elements that contain human cells or tissues. Such elements could be intended for implantation, transplantation, infusion or transfer into a human recipient.
- Biological medicinal products, defined as products deriving from human tissues or other natural sources. Products of this type are created using culture and purification techniques. The examples of such products are vaccines, blood components, tissues and somatic cells.
- Combination product. To be defined as a combination product, a device should contain two or more elements from different regulation spheres. All combination products can be divided into the following categories and subcategories: (i) Integrated combination products that include at least two elements subject to the regulation integrated into a one product, and (ii) Non-integrated combination product, including co-packed (separate items supplied within one package) and cross-labeled (the labels of the product contain references to another product intended to be used together) combination products.
- The primary mode of action (PMOA) – the way the combination product performs in order to achieve its effect.
The document also contains other definitions used to describe the specific features of combination products. The guidance also provides examples of each particular type of combination products. For example, drug delivery systems (initially filled with the drugs) and devices containing a drug are single-entity combination products; first aid kits and drugs packaged with the device used to deliver them are co-packaged combination products; while light-emitting devices and light-activated drugs together constitute a cross-labeled combination product.
Combination Product Classification in Detail
According to the document, all classification rules applicable to combination products are based on the group of criteria, namely:
- The initial definition.
- The way the device was initially classified by the manufacturer.
- The primary mode of action (PMOA) – this is one of the most important criteria. If the product achieves its intended purpose through ways usually associated with drugs, it should be subject to regulation under the drug framework. However, if it achieves its intended purpose in another way, it should be subject to regulation as a medical device respectively.
- In case the modes of actions the product has are equal, the final determination should be made depending on the safety and efficacy aspects of the product as a whole.
- Notwithstanding the determination, all elements of the product should comply with applicable safety and performance requirements.
The guidance also describes the procedure to be applied in order to determine properly the class of the device. The procedure provided in the document includes the following consecutive steps:
- An applicant requiring classification should submit an appropriate request using the electronic-Products Classification System (ePCS).
- The request should be reviewed by the Products Classification Department (PCD) which should indicate whether the product subject to review is a combination product or not.
- The same authority should indicate the primary (leading) sector and consulted one depending on the distribution of the modes of action.
- The determination should be made by the PCD. In a case the authority fails to make a proper determination, it can forward the request to the Joint Advisory Committee for Regulating and Classification of Combination Products.
- An applicant has a right to appeal. This procedure could be performed using the same ePCS system not later than 60 days after the decision was received by the applicant.
In accordance with the general rule, the application should comply with the requirements set forth in the appropriate guidance for the applications related to the leading sector assigned to the device.
Combination Products Registration Timelines
Depending on the leading sector, the combination product could be defined as a drug – medical device combination product or as a medical device – drug combination product, and the particular terms would depend on the determination.
Depending on the type of the submission, for drug-medical device combination products, the guidance provides the following timeframes for marketing authorization:
- Submission for the new drug – 290 working days,
- Submission for the new drug that is not registered in the SRA – 415 working days,
- Medicinal Biological – 290 working days,
- Medicinal Biological, that is not registered in the SRA – 415 working days,
- Radiopharmaceutical – 290 working days,
- Generic – 165 working days,
- Submission for the renewal – 70 working days.
The timeframes for marketing authorization of the medical device – drug combination products depend on the class of risk of the device subject to review in accordance with the risk-based classification. In particular, the guidance provides the following timeframes:
- For Classes A to D – 35 working days,
- For In-Vitro Diagnostic medical devices of all classes – 35 working days,
- For HCT/Ps – 35 working days.
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