From January APIs shipped to the European Union (EU) must be made in compliance with good manufacturing practices (GMP) or equivalent standards such as the WHO's GMP for Active Substances and ICH Q7.
And from July exporters outside the EU must provide this proof in the form of a letter from a competent local inspection authority that accompanies the API shipment.
The only exception is if the exporting country has been granted an exemption by the EU, however, to date no country has had the letter requirement waived although Switzerland, Israel, Australia, and Singapore have asked.
Rx360 has some serious reservations about the new rules, foremost of which is that they may cause suppliers in countries like India and China - which make 80 per cent of the APIs sold in Europe - to focus on other markets.
"There are concerns that major markets may balk at these requirements. Active substances that are imported into the EU without written confirmation will likely be significantly delayed or rejected by EU member state customs."
And while India's recent decision to set up an authority to make sure exporters comply with the rules may alleviate some of these concerns, individual manufacturers may still choose to sell their products elsewhere if compliance proves to be too complex or time consuming.
The drug industry supply chain organisation also raised concerns that the burden for ensuring that the compliance letter is legitimate falls on the firm importing the ingredient rather than the exporter.
“It is the responsibility of Finished Drug Product manufacturers who is receiving the imported API to verify the written confirmation,” the supply chain group said, advocating that drugmakers should make sure “API suppliers are aware of the new guidelines to ensure the supply of medicinal products is not disrupted.”
“Active substances that are imported into the EU without written confirmation will likely be significantly delayed or rejected by EU member state customs” it added.
Rx360 goes on to suggest that exports from countries that refuse to provide confirmation letters, or those that do not have the legal authority to conduct inspections are likely to be denied entry to the EU.
The organisation also envisages problems in countries that do not comply with the EUs rules even despite having the necessary inspection infrastructure.
“Countries that would fulfill the equivalence assessment of the regulatory framework and the respective control and enforcement activities, will not all request to be granted exemptions by the EU Commission.”
Drugmakers, API manufacturers and other parties that will be affected by the new laws are asked to take part in an Rx360 survey, available here. The deadline for submissions is November 1.