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Eight African Agencies Finalizing Reliance Mechanism To Speed Drug Approvals

A new reliance pathway under which regulators will rely on each other’s assessment reports strengthens the goals of key continental health initiatives, including the newly formed African Medicines Agency.

Malaysia’s MDA At Asia Forum: ‘Regulatory Silos Are Not The Way Forward Anymore’

MDA, the Malaysian medical devices regulator, told the 2025 APACMed conference about its efforts on regulatory convergence, harmonization and reliance, which are top of its priority list for aiding medtech regulatory workflows and granting faster access to innovative devices.

Global Pharma Guidance Tracker – September 2024

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.

Global Medtech Guidance Tracker: September 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Global Pharma Guidance Tracker – August 2024

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.

Global Medtech Guidance Tracker: August 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.

Global Pharma Guidance Tracker – July 2024

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.

Global Medtech Guidance Tracker: June 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Final Funding Blow For J&J’s Spravato In England, Despite Reimbursement In 26 Other Countries

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.

Global Pharma Guidance Tracker – May 2024

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.

Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses

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.

Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses

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.