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Wealth Of MedTech Innovator Asia Pacific Entries Underlines Rising Caliber Of Local Technologies

The culmination of the MedTech Innovator APAC awards program 2025 comes later this month when the top prizes are handed out at the grand final in Singapore. But all cohort companies benefit from the competition’s mentoring process, says awards organizer Fredrik Nyberg.

Don’t Wait! Early Talks With Device Innovators Pay Off, Say Australia, Malaysia Regulators

APACMed 2025 delegates heard how two global device regulators have shifted to a policy of early advice for innovators, with benefits for all industry stakeholders.

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.

Regulatory Recap: Swissmedic Reduces Review Times For Generics By Six Months

Generics Bulletin reviews global regulatory developments across the world.

Malaysia Clarifies Drug Shortage Reporting Rules And Penalties For Non-Compliance

New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.

Biocon Agreement Provides Multiple Oncology Biosimilars To Malaysian Cancer NGO

Biocon Biologics will look to combine its “scientific expertise with the National Cancer Society of Malaysia’s strong community outreach and patient support network,” after signing striking up a partnership with the NGO providing for supply of three biosimilars.

Regulatory Recap: UK To Capture £1bn Savings With Framework For Best-Value Biologics

Generics Bulletin reviews global regulatory developments across the world.

Regulatory Recap: EU Pharma Groups Advocate For Electronic Product Information Rollout

Generics Bulletin reviews global regulatory developments from late 2024 and new updates from this year.

Regulatory Recap: EU’s Wastewater Directive Threatens Generic Industry, Medicines For Europe Says

Generics Bulletin reviews the latest regulatory developments across the world.

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 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.

Malaysia Tests Regulatory Reliance To Speed Up Access To New Indications

The Malaysian agency’s drug review mechanism that relies on assessments by overseas regulators is now being tested for applications seeking approval for additional indications.