New medicinal products that use gene therapy, cell therapy and tissues engineering, that can be used to treat disease or injuries, such as skin in burns victims, cancer, muscular dystrophy or Alzheimer’s have huge potential.
EU Regulation on Advances therapies facilitate access to market while guaranteeing the highest level of health protection. Some elements of the Regulation are: centralized marketing authorization procedure
a multidisciplinary expert Committee, technical requirement adapted and special incentives for small and medium sized enterprises.
The Regulation recognizes that some advance therapy products combine biological materials, such as tissues or cells, with chemical elements, such as metal implants or polymer scaffolds, require adapted requirements.
Medical device trials require an added level of specialized service and regulatory knowledge to be executed successfully. Medical device clinical trials have many similarities to those for pharmaceuticals, but the regulatory evaluation of devices is distinct with critical differences:
- Class of the device or risk stratification varies the requirement for a clinical trial, to demonstrate effectiveness consistently meets the labeled application.
- Safety reporting. For devices, manufacturers are required to report all SAEs, even if they are not directly related to the device or the procedure in which the device is used. This requirement applies not just to implantables, but also to in vitro devices and diagnostics which are not used directly by the patient.
- Clinical trial design and population studied, Medical devices may not be appropriate to insert the device into healthy subjects. Instead, a device trial may be initiated in a small pilot population with the disease or condition under study before moving into the larger pivotal populations.
- Clinical Trial classification, varies from medicinal products.
- Exploratory Study at early stages of device development.
- Pivotal Study to demonstrate the device is safe and effective for a specific use within a defined patient population and it’s used to gain regulatory approval to market the device.
- Postmarket Study
Being familiar with the specifications and format of drug and medical device clinical trials is crucial to ensure the trials run as smoothly and efficiently as possible.
Just like a clinical study in people, a veterinary clinical study involves research that gains information from animal patients.
Regulatory requirements for veterinary clinical studies have been developed over the years. It’s important to outline the International Conference on Harmonization for Technical Requirements for Registration of Veterinary Products (VICH) Good Clinical Practice (GCP) guidelines (GL9) for best practice on clinical study performance.
Unlike human clinical trials, the subject of a veterinary clinical trial may be owned by the research facility (experimental) or may be a client-owned patient. It is important to distinguish the source of experimental subjects for a veterinary clinical trial as certain types of bias can be more easily minimized when using experimental animals. Because subject variability (for example, differences due to age, breed, sex, diet, environment, or disease) can be more easily standardized.
Current regulations on cosmetic products provides a robust, internationally recognized regime, which reinforces product safety while taking into consideration the latest technological development, including the possible use of nanomaterials.
To access to the European Commission database for information on cosmetic substance and ingredients click here CosIng