Singapore

IMDRF’s playbook on regulatory reliance was in the spotlight at the Forum’s 29th meeting this week, on the heels of its new midterm regulatory strategy document. 2026 IMDRF chair Singapore used the occasion to announce unprecedented WHO acclaim for the nation’s device regulatory oversight.

A decade ago, China was buying Western drugs. Now it is selling them. Executives who ignore the shift do so at their peril.

Gero AI has secured major pharma partnerships in aging space despite raising only $17M, punching well above its weight class.

Joint Singapore-UK plan underlines direction of travel for MHRA after its embracing of international reliance (IR). Australia’s TGA has also broken new ground by recognizing the UKCA mark.

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.

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.

Teva will now market biosimilar Herceptin in both the US and Europe, after penning an agreement with Singaporean firm Prestige BioPharma for its Tuznue rival to the monoclonal antibody to treat HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

Medtech innovators in the APAC region have in recent years seen a slowdown in investment following a combination of rising costs, supply chain challenges and inflationary pressures. But there is light at the end of the tunnel, says MedTech Innovator APAC leader Fredrik Nyberg.

Axcynsis is developing a derivative of the chemotherapy agent Yondelis as a new payload, which the Singapore venture will first apply to a Claudin 6-targeting ADC it plans to take into a Phase I trial in the US, its chairman, CEO and founder tells Scrip in an interview.

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.

Companies will initially be able to submit their dossiers to the Health Sciences Authority via the eCTD portal on a voluntary basis.

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.