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Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good manufacturing practices.

The European Medicines Agency (EMA) has finalized updated guidance on the information required for the manufacture and control of active substances used in medicinal products, with a 1 September date of application.

The US Food and Drug Administration (FDA) recently sent warning letters to three companies concerning facilities in India and one in Germany for current good manufacturing practices (GMPs) and nonclinical study-related violations.

The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing practices (cGMPs), which included issues related to data integrity.

Numerous pharmaceutical industry groups are advocating for the expansion of the US Food and Drug Administration's (FDA) PreCheck program to cover existing manufacturing facilities, as well as new ones. Additionally, some groups recommend that PreCheck be integrated with current programs. The generic drug industry has also suggested that other government initiatives and support should be implemented to strengthen this sector.

As a part of the effort, IPC created a short film on PvPI, a pharmacovigilance comic published in multiple vernacular languages to enhance public awareness, and a new online reporting platform designed for easy access through a QR code.

The US Food and Drug Administration (FDA) on Tuesday published a warning letter to Indian drugmaker Hikal Limited for supplier evaluation and its handling of complaint investigations. The agency also warned an oncologist for failing to follow clinical trial enrollment protocols and for failing to obtain informed consent from a trial participant.

Malaysia's Medical Device Authority (MDA) and Singapore's Health Sciences Authority (HSA) unveiled a pilot program that could accelerate access to Class B, C, and D medical devices. The pilot program begins on 1 September and runs through 28 February.

The US Food and Drug Administration (FDA) is seeking public input on its PreCheck program, which aims to establish new pharmaceutical manufacturing facilities in the US to enhance the pharmaceutical supply chain.

On 13 August, President Donald Trump issued an executive order directing the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) to identify 26 drugs that are essential for public health. The executive order also mandates that a six-month supply of active pharmaceutical ingredients (APIs) necessary for manufacturing these drugs be stockpiled. ASPR has 30 days to compile this list of essential drugs.

The US Food and Drug Administration (FDA) has cited several manufacturers for failing to conform to current good manufacturing practices (CGMP) and quality system regulation (QSR) requirements. The agency also warned several online retailers for illegally marketing Schedule II stimulants, opioids, and benzodiazepines.

This is what six regulatory affairs professionals learned from their experience at the RAPS Kellogg Executive Development Program.

Two pharmaceutical industry representatives told the House Energy and Commerce Health subcommittee on Wednesday that offering tax credits and long-term purchasing commitments to domestic pharmaceutical manufacturers would enhance the US manufacturing base.

The US Food and Drug Administration (FDA) has sent another warning letter to online retail giant Amazon for distributing unapproved new drugs. Additionally, three manufacturers of over-the-counter (OTC) medications received warnings for good manufacturing practice (GMP) violations, and a drug compounding pharmacy was warned for making sterile drugs under unsanitary conditions.

Medicine and medical device industry groups have told the EU how they would like the region to respond to tariffs the Trump administration has imposed on imports into the US. The talks took place before 9 April, when US President Donald Trump paused the higher tariffs on the EU for 90 days.

Two House Energy and Commerce committee hearings on Tuesday – one focused on the reauthorization of the Over-the-Counter Monograph Drug User Fee Act (OMUFA) and the other on cybersecurity vulnerabilities in legacy medical devices – were sidetracked by reactions to the mass firing of staff at the US Food and Drug Administration (FDA) and other federal health agencies that unfolded as the hearings took place.

The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the production of sterile drugs and over-the-counter (OTC) products. Two of the warning letters identified data integrity issues, and failures in component testing were a recurring theme in the others.

TGA began investigating potassium salts after receiving a request to create a new prescription-only medicine entry for preparations given by injection or infusion. Such intravenous forms of potassium are currently unscheduled.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently announced a new agreement with the African Union Development Agency – New Partnership for Africa's Development (AUDA-NEPAD) to share information on good manufacturing practices (GMP) for pharmaceuticals and active pharmaceutical ingredients (APIs). The agreement aims to enhance capacity building for GMPs among African national regulatory authorities (NRAs).

The US Food and Drug Administration (FDA) has warned an active pharmaceutical ingredient (API) maker in India for falsifying manufacturing records and issued a warning letter to a contract testing lab in China for its lax testing approach.