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CLINICAL TRIALS | The deadline for the transition of clinical trials on medicinal products to the CTIS system has expired
The 3-year transition period for clinical trials on medicinal products to the new European CTIS system ended on 31 January. Therefore, all ongoing clinical trials that were approved under Directive 2001/20/EC should already be covered by the new regulation.
After the transition period, clinical trials that are still active and are not under the CTIS system will be suspended and may be subject to corrective measures and inspections by the Spanish Agency of Medicines and Medical Devices.
The Decree regulating the personalized drug dosage system in pharmacies has been approved in Catalonia
On 28 January, the Government (“El Govern”) approved the Decree regulating the personalized dosage service (SPD devices), which aims to regulate the conditions and requirements to be met by pharmacies in Catalonia for the provision of the pharmacotherapeutic monitoring service with personalized drug dosage systems.
In particular, the service consists of the weekly preparation of a patient's medication by the pharmacist in the pharmacy office, in approved devices (SPD devices), using the following processes:
- Information to the patient or caregiver.
- Assessment of the patient's suitability for inclusion in the service.
- Consent of the patient.
- Collection of clinical and pharmacological information on the patient.
- Review of pharmacological treatment.
- Preparation of the necessary documentation.
- Preparation of the SPD device and quality control.
- Delivery of the SPD device to the patient with the appropriate information.
- Pharmacotherapeutic follow-up.
Launch of the European Commission's new Centre for Biotechnology and Bio-manufacturing
Last Thursday, the European Commission launched the new Biotechnology and Bio-manufacturing Centre as a result of the Commission's Strategy to boost biotechnology and bio-manufacturing in the EU. This initiative aims to support start-ups and SMEs to bring innovative products to the EU market and increase their competitiveness by making regulations easier to understand.