China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
As investors and industry alike try to read the tea leaves of what the upcoming change in administrations holds for the U.S., speculation abounds about what Trump 2.0 will mean for the biopharma and med-tech spaces.
A decade ago, when Asia Pacific Medical Technology Chairman (APACMed) John Collings was running a medtech business in China, he was flying high with multiple rounds of investment under his belt and preparing to launch two new technologies, but the company hit a regulatory hurdle that delayed the launch and he found himself grappling for answers, he told the APACMed Forum held Sept. 5 in Singapore.
To take clinical trial innovation to the next level, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is opening the CDER Center for Clinical Trial Innovation. The center, known as C3TI, “will be a central hub within CDER to support the implementation of innovative approaches to clinical trial design and conduct,” said Kevin Bugin, CDER’s lead for C3TI and deputy director of operations in the Office of New Drugs.
Anvisa launched a pilot program to help Brazilian biopharma startups navigate the regulatory path from the initial phases of product development. In addition to providing regulatory support, the goal of the program is to accelerate the process of drug innovation in the country.
Body: The U.K.’s Medicines and Health Care Products Regulatory Agency (MHRA) has a program designed to facilitate more rapid market access for medical devices of urgent need, and now the agency has put money into the policy.
Pharma companies facing the pricing pressures unleashed by the U.S. Inflation Reduction Act will find little respite in European markets in 2024, as governments erect higher market access hurdles around pricing and reimbursement in a bid to constrain drug budgets.
Israel’s finance ministry has increased the amount of funding high-tech companies with a short runway, including biotechs, can apply for under a fast-track scheme run by independent, publicly funded agency The Israel Innovation Authority, in response to the country’s war against Hamas.
Israel’s finance ministry has increased the amount of funding high-tech companies with a short runway, including biotechs, can apply for under a fast-track scheme run by independent, publicly funded agency The Israel Innovation Authority, in response to the country’s war against Hamas. The program has been boosted by an extra ₪300 million (US$74.7 million), bringing the total budget to about ₪400 million, and from this month will assess applications from startups facing financial difficulties.
Drug discovery in Japan has been steadily declining, and it has reached a crisis point where swift action is needed or pharma companies will leave Japan or stop listing products here, said speakers at the BioJapan 2023 meeting held Oct. 10 to 13 in Yokohama, Japan.
