Regulation

FDA focuses on drug supply chain security

During the last year, the FDA has held a number of public meetings to focus on strategies and issues related to the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA). The DSCSA outlines critical steps to build an electronic, interoperable system by November 2023, to identify and trace certain prescription […]

FDA efficacy recommendations vary for hypogonadotropic hypogonadism drugs

New draft industry guidance from the U.S. Food and Drug Administration (FDA) underscores the importance of randomized, double-blind, placebo-controlled trials to establish the efficacy of drugs to treat male hypogonadotropic hypogonadism when it is caused by obesity or another acquired condition. The draft guidance also asserts the potential importance of patient-reported outcome (PRO) instruments to […]

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. […]

Generics industry sets record for U.S. approvals, has ‘nothing to apologize for’

Download the full report. At the 2018 Association for Accessible Medicines (AAM) annual meeting, experts highlighted the generic industry’s recent accomplishments while noting that many challenges lie ahead. On the positive side for the industry, as noted by Jeff Watson, chairman, president and COO of Apotex, a controversial rule change regarding generic drug labeling in […]

Health technology assessment agencies play pivotal role in patient access to medicines

Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensuring patient access to the medicines they need, a study by the Centre for Innovation in Regulatory Science (CIRS) has confirmed. As part of an ongoing effort to monitor regulatory and HTA performance, CIRS collected data on new active substances (NASs) […]

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 […]