Four out of five pharma cos will meet serialization deadlines; poll

A survey has found that 81 per cent of pharma manufacturers expect to meet international deadlines for adding serial numbers to medicine packs.

While encouraging, the GS1/Enterprise System Partners readiness poll still suggests that a sizeable minority of players could be at risk of not being compliant when serialization requirements in Europe, the US and elsewhere come into play in the coming years.

Bar code standards company GS1 Ireland and life sciences consultancy ESP carried out the survey in conjunction with a May webinar on global serialization regulations that attracted delegates from around the world.

The majority of respondents (around 62 per cent) said they had already started implementing serialization on packaging lines, with 12 per cent saying the process was complete for known markets. The remaining 38 per cent indicated they were still in the planning stages.

Interestingly, a third of respondents said they intend to implement aggregation on all their sites - in other words linking each individual medicine pack to the carton or case in which it is shipped - regardless of statutory obligations.

Aggregation is included in the Drug Supply Chain Security Act (DSCSA) in the US and - while not mandated directly - is considered to be implicit in the EU Falsified Medicines Directive (FMD).

ESP managing director Liam O'Brien welcomed the high priority serialisation is being given at corporate level now that deadlines are rapidly approaching.

"While 58 per cent of respondents are well underway in their serialisation implementation, the most pressing concern surrounds the potential for further regulatory changes as well as insufficient time, based on current deadlines," he said.

Among other findings were that almost three-quarters of those polled believe it now takes less than 12 months to serialise a packaging line, with 13 per cent suggesting this can be achieved in less than six months.

"Serialization aids in eliminating many of the gaps associated with traditional pharmaceutical production and distribution that leave manufacturers susceptible to product falsification," concludes the report.

"The biggest benefits of serialisation are seen in the areas of patient safety, supply chain management, business continuity and brand protection."

GS1 also provides an update on serialization deadlines in major world markets, as follows:

EU: Feb 2019;

USA: Nov 2017 (lot level) 2023 (unit level);

Brazil: Pending consultation from Anvisa (Sep16);

Saudi Arabia: Mar 2017;

China: Regulations suspended. Clarification pending;

India: Clarification pending;

Philippines: GTIN lot & expiry required. No serialisation regs to date;

South Korea: Serialization regulation in place; and

Russia: 1 Jan 2017 critical drugs; 1 Jan 2018 vital drugs; all medicines by 1 Jan 2019.