Regulatory

Regulatory reform in China enhancing clinical trials review and approval

In order to encourage innovation, speed up access to new drugs and meet the needs of patients, an updated investigational new drug (IND) review procedure was created in China and has been in effect for just over a year. The change drew discussion at both the DIA China 2019 meeting in Beijing in May as […]

Record new drug approvals: ‘fleeting success’ or here to stay?

With a record 59 new drugs approved by the FDA and 42 new active substances recommended for authorization by the European Medicines Agency, 2018 was a profoundly productive year for biopharma. In a new analysis, Jamie Munro and Helen Dowden from Clarivate Analytics examine whether 2018 represents “a fleeting success” or if there are underlying […]

Drug development challenge: Managing CMC submissions

In the era of Breakthrough Therapy and Fast Track drug designations, chemistry, manufacturing and controls (CMC) submissions can cause delays to bring a drug to market, said Drew Barlow, vice president, regulatory affairs at Syner-G Pharma Consulting.  Companies need to provide enough information to satisfy the regulatory requirements while recognizing that providing too much information early will […]

How regulation, innovation, quality and access are inevitably intertwined

In a global industry like pharmaceuticals, the interdependencies among quality, access, innovation and regulation can have global implications. That message comes through clearly in the 2018 CPhI Annual Report, the compilation of expert forecasts and analyses that the organization puts together. The articles, with their focus on the future direction, technologies, opportunities and threats in […]

Algeria, Morocco and Tunisia changing their regulatory landscape?

Algeria, Morocco and Tunisia have fantastic potential for development in the pharmaceutical sector but weaknesses in some aspects of the pharma regulatory system create barriers to market access. Conscious of this, regulatory authorities in the region say they are determined to improve regulatory processes to allow faster access to market for essential and innovative medicines. […]

Steps taken to streamline regulatory processes in the Middle East

When the DIA’s Middle East Regulatory Conference convened in Kuwait late last year, an array of hot topics drew considerable discussion. The gathering, which brings together multiple stakeholders from multinational companies, local manufacturers and agents/distributors with representatives of health authorities from across the region, focused on verification/reliance procedures, lifecycle management, harmonization initiatives, pharmacovigilance, barcoding, serialization […]

The impact of the changing regulatory environment on the approval of new medicines, 2007-2016

Over the last decade, 2007-2016, convergence in approval times as well as changes in strategies of multinational pharmaceuticals have resulted in more new active substances (NASs) being internationalized, referring here to receiving marketing authorization in six major regulatory agencies, namely the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the Japan Pharmaceuticals […]

Green light to market Hemlibra for hemophilia A with inhibitors in the US

This article is a Clarivate Analytics Market Insight report, an ongoing series featuring expert reviews of hot topics in the pharma/biotech field, with analysis and discussion on the factors currently affecting the industry.   Roche Holding’s Hemlibra (emicizumab-kxvh) has been approved in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding […]

Accelerating – and maintaining – drug approvals in the U.S.

Bringing a drug to market is the ultimate milestone for any pharmaceutical firm that has invested significant effort, not to mention time and resources, into developing its product. But all that work and outlay does not stop at marketing approval—this achievement must be maintained. There can be various regulatory requirements that a firm must meet […]