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Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies and secure the supply of generics and biosimilars.

A new pilot aims to take Brazil closer to ‘digital transformation.’

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

The European Commission’s new research and innovation funding scheme should have a higher budget and be more “flexible and fit-for-purpose” than the existing “one-size-fits-all approach,” pharma industry federation EFPIA says.

A new requirement for drug companies on how much safety stock to maintain and a mechanism for extending the expiration date of a lot or batch of a drug if there is a shortage that could cause harm are among the measures Health Canada is proposing to adopt.

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

Companies submitting clinical data for publication under the European Medicines Agency's Clinical Data Publication policy and Health Canada's Public Release of Clinical Information initiative can now provide a single anonymization report to both regulators. This report would explain the steps taken by sponsors to ensure the anonymized data poses a low risk of re-identification.

J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Ninety-two approvals, seven revocations and myriad standard-of-care treatments are all discussed in a first-of-its kind study examining the data and nuances of oncology submissions processed under Health Canada’s 26-year-old notice of compliance with conditions (NOC/c) pathway.

A new federal law aims to promote the conduct of trials and speed up access to innovative drugs in Brazil.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

Adult immunization programs can save “billions” for society, but their value is underestimated because of challenges around measuring broader value evidence and a lack of incentives for companies to collect this data, says the Office of Health Economics.

Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies.