• Regulatory NewsRegulatory News

    Swissmedic Begins Working With EudraGMDP Database

    As part of the mutual recognition agreement between the EU and Switzerland, the Swiss Agency for Therapeutic Products (Swissmedic) has begun entering information on good manufacturing practice (GMP) compliance and manufacturing authorizations into the EU’s EudraGMDP database. The European Medicines Agency (EMA) noted on Thursday that the Swissmedic entries apply to all new or renewed manufacturing authorizations and the related GMP-certificates issued using new template...
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    German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies

    Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories. The non-compliance report calls out the site, which manufactures and packages non-sterile capsules and tablets, for one critical deficiency related to the essential elements of its...
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    Updated: MHRA Suspends UK Company's MS License

    Late last month, the UK's Medicines & Healthcare products Regulatory Agency (MHRA) suspended the manufacture specials (MS) license of a UK company that recently made a push into the US. The MHRA did not reveal what caused it to suspend Bionical Limited's license , but according to MHRA's most recently updated list of suspensions, the license is suspended until 18 February 2016. Jonathan Hughes, business development director of Bionical, told RAPS that the suspension c...
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    Indian API Manufacturer Faces Canadian Quarantine Over Data Integrity Issues

    After Slovenian inspectors uncovered serious issues at Indian active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories, Health Canada has issued a voluntary quarantine for all products containing APIs sourced from the company. Background On 18 March 2015, inspectors from Slovenia's drug regulator JAZMP uncovered evidence of serious good manufacturing practice (GMP) deficiencies at Polydrug's facility in Maharashtra, India. In their report, filed to the...