The Malta Independent 25 June 2019, Tuesday

Academy on Regulatory Sciences for medicinal cannabis products in the works

Jeremy Micallef Wednesday, 29 May 2019, 11:28 Last update: about 26 days ago

The Medicines Authority is currently working to establish an Academy on Regulatory Sciences to strengthen the emphasis on the production of high-quality products, including medicinal cannabis products, Chairman of the Medicines Authority Anthony Serracino Inglott said.

The Medicines Authority today hosted the Organisation for Professionals in Regulatory Affairs (TOPRA) Conference on the Regulatory Sciences – As applicable to Cannabis for medicinal and research purposes.

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The seminar hosted professionals from various field and nations, including speakers from diverse professional backgrounds.

This comes as Malta passed the Drug Dependence Bill in March 2018 approving medical cannabis with a prescription,  and a separate law to regulate the production of medical marijuana products from which local and foreign investments have already transpired.

Serracino Inglott noted that the opening of this academy is necessary considering a number of products on the market that are not considered to be of the desired quality.

Speaking at the conference, Parliamentary Secretary for Consumer Rights Deo Debattista (photo) said that “there has been an evident need to meet patient and prescriber exigencies for forms of cannabis for medical use”, noting that major bodies, such as the United Nations, the World Health Organization and the European Parliament, are all evaluating the evolvement in the medicinal cannabis field. 

“Since the recent local legislative amendments, Malta has featured in countless media reports, important conferences and discussions all over the globe.” 

Debattista explained that whilst “some may say we’re easy, others may think we’re too strict”, proper consultation with all the stakeholders will help allow the Authority “spearhead the regulation of cannabis”, and “drive effective developments that translate into tangible outcomes”.

“Our forward-looking response should address the difficulties posed by those who are still hesitant to endorse the use of cannabis for medicinal purposes.”

He maintained that research and development is pivotal, with safety, quality and efficacy being “the three pillars at the forefront of the regulation of medicines”.

“The regulation of medical cannabis in Malta follows a route, comparable to that implemented for the pharmaceutical industry and controlled medicines in liaison with the Superintendence of Public Health, with particular emphasis on quality standards and good manufacturing practice.” 

This, he clarified, is supported with investments in capacity building, the engaging of pertinent experts, the issuing of guidance documents, and the holding of scientific consultations, including strong collaboration with Malta Enterprise and the Univeristy of Malta that is being extended to other organisations who intend on making Malta their European Hub.

“This programme will provide an understanding on the application of regulatory sciences to all activities related to cannabis for medicinal use.”

“The importance of research and education in the contribution that Malta is giving and plans to expand, is pivotal to the strategy laid for the development of cannabis for medicinal use.  I am certain that the knowledge and skills gathered shall portend further success in our future endeavours.”

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