Regulatory Oversight and Compliance

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

Drug developers understand the importance of early communication with regulators, but is EMA providing enough flexibility and support to companies?

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.

More reliable operations would accelerate product development and prevent drug shortages.

Hope abounds for local drug discovery companies despite challenges at home.

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

Scientists and industry experts seek effective preventive therapies to combat global disease.

Proposals to make the decentralized procedure more efficient were discussed at the January 2015 EGA conference.

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

Cleanability is crucial when choosing components for GMP manufacturing areas.

The company voluntarily recalls product due to FDA observations of potential sterility problems.

The agency cites Apotex’s Bangalore facility with quality system failures.

The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

The agency releases five draft guidance documents related to drug compounding and repackaging.

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.

Biosimilars, supply chain security, quality metrics, and elemental impurities headline guidance topics on FDA’s 2015 agenda.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

Changes in the country’s political landscape may affect the pharmaceutical industry market in the future.

The agency creates an electronic central repository to facilitate drug safety assessment reports.