In this week’s news, US FDA puts timeline on ANDA responses, EMA rolls out scientific advice online and more…
US FDA issues draft guidelines on responding to ANDA rejections
The US FDA has issued draft guidance for generic medicine makers whose abbreviated new drug applications (ANDA) it rejects.
The document sets out how companies should address “complete response letters.” Firms can either resubmit with additional information, request an appeal or withdraw the application within a year.
Companies that fail to take one of these actions will be considered to have requested withdrawal.
Traditionally the agency has grated requests for multiple extensions to allow companies to respond to an individual CRL to the detriment of the ANDA assessment process.
“Lengthy response times because of multiple extensions, which can result in applicants submitting an amendment addressing deficiencies years after the initial assessment of the ANDA and issuance of the CRL, are disruptive to the assessment process and can create additional assessment cycles.”
EMA to begin giving online scientific advice
The EMA has launched an online platform for drug firms and CDMOs seeking scientific advice.
The agency has added functionality to its IRIS platform to let developers ask for guidance on the best methods and study designs to generate robust data on how well a medicine works and how safe it is.
The EMA said it will “provide a single space for applicants and EMA to submit requests, communicate, share information and deliver documents concerning each scientific advice procedure.”
The IRIS portal was launched in 2018. In addition to scientific advice, drug firms can apply for orphan designation, ask for notification of parallel distribution, apply for meetings with EMA’s Innovation Task Force, and request Research Product Identifiers for new medicinal products.
EU reliance on Asia made APIs a problem says German generics sector
European drug makers need to diversify supplies to avoid shortages according to a report, which points to the continent’s reliance on APIs from Asia as a problem.
German generics industry lobbying group Pro Generika published its report last week. The authors wrote that “The majority of the active pharmaceutical ingredients that are prescribed and needed in Germany come from Asia.
“Europe has lost its former top position in the manufacture of active ingredients: Two thirds of the approvals required for production are located in Indian and Chinese locations, which are spread over only a few provinces.
They added, “There are no European manufacturing facilities for around a sixth of the generic active ingredients examined.”
Read more from Reuters.
US FDA launches manufacturing data portal for drug firms
The US FDA has launched an online portal to which drug companies can submit manufacturing capacity data.
The portal allows firms to submit provide information about the specific investigational new drug (IND) application and the manufacturer, along with details of production rates, treatment courses, clinical trials and allocations.
The agency said, “This solution provides a way for organizations to submit data related to manufacturing capacity to the FDA to analyse and support manufacturing efforts for potential vaccines and therapeutics.”
Also in the news
The outsourcing sector has had a difficult 2020 according to Chemical & Engineering News, which reports the Covdi-19 pandemic has created opportunities and challenges for CDMOs.
Pharma Manufacturing looked at US efforts to encourage local drug and API manufacturing. The authors suggest concerns about global supply chains have been exacerbated by the pandemic.
Contract Pharma spoke to drug companies using quality risk management to ensure medicines get to market faster and secure supply chains.
DCAT examined the impact of a “no deal” Brexit for the pharmaceutical industry.
Pfizer has invested in gene therapy manufacturing capacity according to Fierce Pharma.
CNBC reported on political investigation of alleged Whitehouse efforts to influence the CDC and FDA.
Some developments of note in the contracting sector:
Siegfried has agreed to buy two plants in Spain from Novartis. The firm said the deal will help it “achieve the targeted critical size in the field of drug products, thus creating further potential for profitable growth in the highly attractive CDMO market.”
Johnson & Johnson has hired Grand River Aseptic Manufacturing to make its SARS-CoV-2 vaccine candidate. The agreement includes the technical transfer and fill and finish manufacture.
Ajinomoto Bio-Pharma Services will make medicines for the partnership with the Drugs for Neglected Disease Initiative (DNDi). The firm will make a CpG oligonucleotide, as part of a combination therapy used in the treatment of leishmaniasis.
Sterling Pharma Solutions has agreed to buy Alcami’s facility in Germantown, Wisconsin. The plant will make APIs.