Anavex Life Sciences Corp (AVXL)

[sokol]

PDD/AD trials in Australia/Spain. Members of the European Union share in the exchange of information about clinical trials through mutual recognition agreements, and Australia also is involved in the exchange of scientific information with members of the European Union. It makes sense that Australia and Spain would share in the exchange of information about clinical trials and developments that occur within the European Union and Australia. Why not? After all, it is in the best interest of Spain and Australia, assuming those countries are sincere about curing their citizens diagnosed with these dreaded diseases, PDD and AD. See this about mutual recognition agreements regarding EU members and Australia.

Mutual recognition agreements (MRA)
https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra

Clinical trials in human medicines
https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials-human-medicines

“Clinical trials in human medicines Share
The European Medicines Agency relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. Although the of clinical trials occurs at Member State level, the Agency plays a key role in ensuring that the standards of good clinical practice (GCP) are applied across the European Economic Area (EEA) in cooperation with the Member States. It also manages a database of clinical trials carried out in the European Union.

Clinical trials are studies that are intended to discover or verify the effects of one or more investigational medicines. The regulation of clinical trials aims to ensure that the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible.

Regardless of where they are conducted, all clinical trials included in applications for marketing authorisation for human medicines in the European Economic Area must have been carried out in accordance with the requirements set out in Annex 1 of Directive 2001/83/EC. This means that:

clinical trials conducted in the EEA have to comply with European Union (EU) clinical-trial legislation (Directive 2001/20/EC);
clinical trials conducted outside the EEA have to comply with ethical principles equivalent to those set out in the EEA, including adhering to international good clinical practice and the Declaration of Helsinki.
In the EEA, approximately 4,000 clinical trials are authorised each year. This equals approximately 8,000 clinical-trial applications, with each trial involving two Member States on average. Approximately 61% of clinical trials are sponsored by the pharmaceutical industry and 39% by non-commercial sponsors, mainly academia.’’

https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/australia

“Australia
The European Medicines Agency and the European Commission have had confidentiality arrangements with the Therapeutic Goods Administration (TGA) of the Australian Government Department of Heath and Ageing since 2012, to allow the exchange of information between the parties as part of their regulatory and scientific processes. The European Union (EU) and Australia also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.’’