In this week’s news, Brazil tightens QC testing regulations, US FDA busy despite ongoing shutdown, IFPMA bans gifts, Holland welcomes EMA and more…
Brazil moves to limit QC and storage outsourcing
Brazilian regulator ANVISA has introduced measures that will prevent drug importers from outsourcing quality control and storage.
According to Directory Board Resolution (RDC) 257/2018, companies that import pharmaceutical products into Brazil must now have both their own QC laboratory and warehouse facility.
The resolution – which allows firms with existing storage facilities to outsource the management of excess inventory – will apply until December 2020 when the agency is due to decide whether to adopt it for the long term.
Read the full resolution here (Portuguese). Visit the ANVISA website for more information.
Analysts suggest the Brazilian pharmaceutical market is worth $25bn a year and that it will grow to a value of nearly $30bn by 2021. Last year, Pharma Exec put together detailed analysis of the country’s drug market.
Calls for US FDA to get full agency status; reports on 2018 safety efforts
Former US FDA Commissioners say the Agency would be better able to oversee the safety and efficacy of drugs sold in the US if it were a separate agency.
The proposal would see the US FDA split from the Department of Health and Human Services (DHHS) and become a stand-alone organisation.
According to the ex-commissioners a separate FDA could better “leverage science and technology in support of public health and safety while also fostering therapeutic and technological innovation and transparent decision-making.”
The full article can be purchased here.
…US FDA details site engagement plan
In related news, the US FDA has shared details of its efforts to engage with pharmaceutical manufacturers that make key drugs.
According to the FDA the “site engagement programme” – which was first mentioned in 2017 – is based on the idea that enhanced interaction between the Agency and identified sites will help to mitigate shortages.
Under the plan, firms that manufacture finished drugs that, if supply were disrupted, would result in higher risk to patients have been invited to meet with the FDA to discuss how to prevent potential shortages.
In other news, the Agency – which like much of the US Government is being impacted by President Donald Trump’s shutdown – has published a report on its efforts to oversee drug safety in 2018.
It has also shared details of its plans for enhanced oversight of medical devices in 2019. Read more here.
IFMPA bans drug company gifts for doctors
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has banned drug firms from giving doctor gifts.
The organisation – which represents research-based drug firms around the world – issued the change in a revised version of its code of practice.
Director General Thomas Cueni wrote, “We are placing a global ban on gifts for any company that is a member of IFPMA, and for all those firms that are members of our regional and national associations.
“This new revised Code is more principles-based and seeks to embody a deeper and broader appreciation of business integrity” he said.
Previous versions for the code included exceptions “based on the custom of gifts to mark significant national, cultural or religious events.”
The move will be welcomed by those concerned that gifts given to doctors by pharmaceutical companies impact prescribing decisions.
Holland welcomes the EMA
The Dutch Ministry of Foreign Affairs has welcomed the European Medicines Agency (EMA) as it prepares to leave London ahead of Brexit.
Welcome @EMA_News! #KingdomNL welcomes the European Medicines Agency in Amsterdam in their new temporary premises. Successful visit of EU-Ambassadors. Follow @relocatemaEN for updates. pic.twitter.com/dXa8Y1MN8f
— Dutch Ministry of Foreign Affairs 🇳🇱 (@DutchMFA) January 9, 2019
The Department announced the EMA’s temporary home, the 11-storey Spark Building in Sloterdijk, was operational last week, explaining the facility has 850 working spaces, 15,000 m2 of floor space, and a conference centre.
Minister of Health Bruno Bruins said the temporary base would prevent EMA operations being interrupted during the transition, adding “It’s crucial to millions of patients in Europe that EMA be able to monitor the safety and quality of medicines unhindered”
MHRA plans to stay close to FMD
The MHRA has concluded it will adhere to most of the measures in the European Union’s Falsified Medicines Directive after Brexit.
The UK regulator made its intentions clear last week.
Read a full review from Securing Industry.
Also in the news
Donald Trump’s claim drug prices have come down in the US is inaccurate according to analysis by STAT.
The ABPI has revised its code of practice to take into account the greater role that digital technologies are playing in the development, manufacture and sale of medicines. See more at the Pink Sheet.
RAPS looked at how Brexit – which was still going ahead when this article was published – is likely to impact regulation of the pharmaceutical industry in Europe.