Australia’s Therapeutic Goods Administration to undergo a AU$12m digital transformation

Australia’s Therapeutic Goods Administration (TGA) is getting a digital makeover, after the federal government announced on Friday it would invest AU$12 million over four years to make it happen.

As part of the revamp, TGA’s business systems and infrastructure will be digitised and cybersecurity measures will be bolstered.

Specifically, it will enable medical companies to use automatic data transfer to deliver drug reaction reports on patient safety from their own internal databases into the TGA Adverse Events Management System (AEMS) database, saving up to 15 minutes per report. This will be a change to the current process that requires reports that are submitted in PDF format, as well as other formats, to be manually entered into the database. 

See also: ADHA details My Health Record breach attempt

Minister for Health Greg Hunt touted the revamp would help cut red tape for more than 4,000 businesses that apply to register medicines and medical devices annually, saying it would result in earlier approvals of medical products.

“The TGA receives around 26,000 applications every year for medicines and medical devices to be listed or amended on the Australian Register of Therapeutic Goods (ARTG), which allows them to be imported, sold, and used in Australia,” he said.

“The digital changes will enable simpler and more secure interactions between government and industry to apply for, track, pay, and manage listings for regulated and subsidised health-related products and services.”

The program is being delivered as part of the federal government’s deregulation agenda, which has been designed to reduce the cost of doing business with government and performing regulatory compliance through targeted technology investment.

The agenda received just over AU$156 million when the Australian government handed down its 2019-20 Mid-Year Economic and Fiscal Outlook at the end of last year.

Earlier this week, the Morrison government announced

Food and Drug Administration Renews and Expands Use of Certara’s Biosimulation Software for Reviewing Regulatory Submissions

FDA’s Office of Pharmaceutical Quality adds new licenses of Simcyp Simulator

Certara, a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has again renewed and expanded its licenses of Certara’s biosimulation software, with more than 400 user licenses of Simcyp™ and Phoenix™ platforms. Eleven divisions and offices of the FDA use Certara’s software for internal research and to independently analyze, verify, and review regulatory submissions.

Certara’s Simcyp Simulator, an industry-leading platform for physiologically-based pharmacokinetic (PBPK) modeling and simulation, is used to determine first-in-human dose, design more efficient and effective clinical studies, and predict drug-drug interactions using virtual populations. The FDA’s Office of Clinical Pharmacology has renewed its licenses for the Simcyp Simulator, including Simcyp Pediatric and the Simcyp Cardiac Safety Simulator. Furthermore, the FDA’s Office of Pharmaceutical Quality recently ordered Simcyp user licenses, expanding the FDA’s use of the platform. The agency uses Simcyp software to independently analyze, verify, and review sponsor IND, BLA, NDA, ANDA, and other submissions.

“Regulators around the world rely on our sophisticated software to inform their reviews of regulatory submissions,” said Rob Aspbury, Ph.D., president of the Simcyp division at Certara. “It is a privilege to continue partnering with the FDA to demonstrate the ever-increasing uses of PBPK modeling to optimize drug development and support the regulatory review process in an effort to bring safe and efficacious therapies to market.”

Additionally, the FDA has renewed its user licenses of Certara’s Phoenix Platform, a comprehensive and widely-used software for pharmacokinetic, pharmacodynamic, and toxicokinetic modeling and simulation. Eleven divisions and offices at the FDA, along with ten other global regulatory agencies such as Japan’s Pharmaceuticals and Medical Devices Agency and China’s National Medical Products Administration, use the Phoenix Platform to evaluate regulatory submissions.

Certara’s customers use Phoenix extensively

Q&A: Will the Trump administration be able to ban TikTok?

Updated


A federal judge on Sunday postponed a Trump administration order that would have banned the popular video sharing app TikTok from U.S. smartphone app stores.

A more comprehensive ban remains scheduled for November, about a week after the presidential election. But the judge, Carl Nichols of the U.S District Court for the District of Columbia, cast doubt on the government’s argument that TikTok is a national security threat because of its ties to China.


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