Euro Roundup: Swissmedic clarifies how foreign manufacturers can demonstrate GMP compliance

The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance document on good manufacturing practice (GMP) compliance by foreign companies with an explanation about the use of audit reports.

Swissmedic requires foreign manufacturers to provide proof that they operate in compliance with Swiss GMP requirements. Generally, manufacturers show compliance by submitting GMP certificates issued by foreign regulators in countries with equivalent GMP control systems. Alternatively, Swissmedic will also accept official documents confirming that the manufacturer satisfies the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP requirements

For companies that cannot use either of the preferred means of demonstrating GMP compliance, the updated guidance features a hierarchy for documentation. It clarifies how companies can use audit reports to show GMP compliance. To be used to show compliance, the audit must be carried out by qualified internal or external auditors and cover all relevant aspects of GMP.

Internal audits must be carried out within the framework of the company’s quality assurance system. If the audit is performed by a third party, the manufacturer must take into account European requirements on the outsourcing of GMP activities. Swissmedic has imposed additional requirements on the use of audit reports from countries whose GMP control system is not considered equivalent to Switzerland’s.

“If an audit report is submitted, a list of the inspections of the manufacturer concerned carried out by foreign authorities within the last five years must also be submitted, including at least the following details: name of foreign authority, date of inspection, date of completion of inspection and outcome (compliant/non-compliant),” according to the updated guidance.

Swissmedic added that it “reserves the right to inspect, at the expense of the Swiss authorization holder/applicant, manufacturers from countries whose regulatory authority does not have a GMP control system deemed by Switzerland to be equivalent to the Swiss system.” The updated guidance clarifies that Swissmedic can put filings on hold until it is able to inspect a facility.

Swissmedic Notice

EMA recommends approval of first vaccine to protect older adults from RSV infection

The European Medicines Agency (EMA) has recommended the approval of the first vaccine to protect older adults from respiratory syncytial virus (RSV) infection. EMA’s recommendation covers the use of GSK’s Arexvy in people aged 60 years and older.

RSV causes an estimated 250,000 hospitalizations and 17,000 in-hospital deaths in Europe in people aged 65 years and older, according to an EMA statement. Several manufacturers, including GSK, Pfizer and Moderna are developing RSV vaccines indicated for use in that population.

EMA recommended Arexvy for approval after reviewing data from a clinical trial that enrolled 25,000 adults in 17 countries. The vaccine was estimated to provide 83% protection against RSV-confirmed lower respiratory tract disease.

EMA evaluated the vaccine candidate under its accelerated assessment pathway, reflecting its view that there is a major public health interest in protecting the elderly population against RSV. The next step is for the European Commission to issue a marketing authorization, at which point GSK will be able to sell the vaccine but will still need to work through the pricing and reimbursement process in each country.

At the same meeting, EMA issued positive opinions on a clutch of other drugs, including Bristol Myers Squibb’s Camzyos (mavacamten). Bristol Myers paid $13.1 billion to buy MyoKardia, the developer of the cardiovascular disease drug.

Press Release, More

UK government explains how MHRA is working to accelerate assessment of clinical trial filings

The UK government has explained why the Medicines and Healthcare products Regulatory Agency (MHRA) is taking longer to assess clinical trial authorization (CTA) applications and what it is doing to speed the process.

MHRA took an average of 45.95 days to issue an initial written opinion on CTA filings in its 2022 to 2023 financial year, up from 27.45 days the prior year and 22.83 days the year before that. The situation got worse throughout the most recent financial year, with the average wait growing from 30 calendar days in June 2022 to 80 calendar days in March 2023.

Members of parliament have questioned whether staffing levels are affecting review times. In response, a representative of the government said the extended review time last year “is the result of increased demand to process applications and respond to queries.”

MHRA has responded by “increasing resources and improving processes in this area,” the government politician said. The agency has filled vacancies at its clinical trials unit and recruited seven new clinical trial assessors over the past year. MHRA is prioritizing the training of its assessors and supporting its new hires “with an additional fixed-term resource of appropriately experienced and qualified specialists.”

Written Response, More

Swissmedic adds section on RWE study design and data sources to medicine application forms

Swissmedic has added a section on real-world evidence (RWE) to its application form for authorizations of new human medicinal products.

Growing interest in the use of data generated outside of the clinical trials typically used to show safety and efficacy has led Swissmedic to update the form companies submit to seek approval. The updated form asks if the application includes RWE to support safety and efficacy.

Applicants that include RWE need to state how they used real-world data (RWD), for example to serve as an external control cohort in a single-arm study. Swissmedic wants to know where the RWD comes from too, giving applications options such as electronic patient records and wearable technologies as options to choose from on the form.

The updated form became valid at the start of May, but companies can also use the old version for the next three months.

Swissmedic Notice

Great Britain plans to accept European CE marks until 2030 under new proposals

The UK government has proposed extending the acceptance of CE marks until 2028 or 2030, depending on the type of certification, to prevent the post-Brexit transition from disrupting the supply of medical devices.

Under the existing law, manufacturers can use European Union CE marks to place devices on the market in England, Scotland and Wales, collectively known as Great Britain, until 30 June. With the government now planning to establish the post-Brexit regulatory framework in July 2025, it has asked parliament to extend the acceptance of CE marks.

MHRA now expects to accept CE marks issued under the outgoing device and diagnostic directives until June 2028 and June 2030, respectively. Device and diagnostic CE marks issued under the new regulations will remain valid until June 2030. If a CE mark expires after Great Britain’s regulatory regime fully applies in 2025, manufacturers will not be able to use renewed EU certificates to stay on the market.

MHRA Notice, More

Euro Roundup: Swissmedic clarifies how foreign manufacturers can demonstrate GMP compliance

Related topics

Recommended content

Welcome to the new RAPS Digital Experience